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CERDELGA Hard capsule (2020)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Cerdelga 84 mg hard capsules.

Qualitative and quantitative composition

Each capsule contains 84.4 mg of eliglustat (as tartrate). Excipient(s) with known effect: Each capsule contains 106 mg lactose (as monohydrate). For the full list of excipients, see section 6.1.

Pharmaceutical form

Hard capsule. Capsule with pearl blue-green opaque cap and pearl white opaque body with GZ02 printed in black on the body of the capsule. The size of the capsule is size 2 (dimensions 18.0 6.4 mm).

Therapeutic indications

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 ...

Posology and method of administration

Therapy with Cerdelga should be initiated and supervised by a physician knowledgeable in the management of Gaucher disease. Posology The recommended dose is 84 mg eliglustat twice daily in CYP2D6 intermediate ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Patients who are CYP2D6 intermediate metabolisers (IMs) or extensive metabolisers (EMs) taking a strong or moderate ...

Special warnings and precautions for use

Initiation of therapy: CYP2D6 genotyping Before initiation of treatment with Cerdelga, patients should be genotyped for CYP2D6 to determine the CYP2D6 metaboliser status (see section 4.2, Special populations). ...

Interaction with other medicinal products and other forms of interaction

Eliglustat is metabolised primarily by CYP2D6 and to a lesser extent by CYP3A4. Concomitant administration of substances affecting CYP2D6 or CYP3A4 activity may alter eliglustat plasma concentrations. ...

Fertility, pregnancy and lactation

Pregnancy There are no or limited amount of data from the use of eliglustat in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see ...

Effects on ability to drive and use machines

Cerdelga has no or negligible influence on the ability to drive and use machines.

Undesirable effects

Summary of the safety profile 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 ...

Overdose

The highest eliglustat plasma concentration observed to date occurred in a Phase 1 single-dose dose escalation study in healthy subjects, in a subject taking a dose equivalent to approximately 21 times ...

Pharmacodynamic properties

Pharmacotherapeutic group: Other alimentary tract and metabolism products, various alimentary tract and metabolism products ATC code: A16AX10 Mechanism of action Eliglustat is a potent and specific inhibitor ...

Pharmacokinetic properties

Absorption Median time to reach maximum plasma concentrations occurs between 1.5 to 6 hours after dosing, with low oral bioavailability (<5%) due to significant first-pass metabolism. Eliglustat is a substrate ...

Preclinical safety data

The principal target organs for eliglustat in toxicology studies are the GI tract, lymphoid organs, the liver in rat only and, in the male rat only, the reproductive system. Effects of eliglustat in toxicology ...

List of excipients

Capsule contents: Microcrystalline cellulose Lactose monohydrate Hypromellose Glycerol dibehenate Capsule shell: Gelatin Potassium aluminium silicate (E555) Titanium dioxide (E171) Yellow iron oxide (E172) ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

PETG/COC.PETG/PCTFE-aluminium blister. Each blister wallets contains 14 hard capsules. Each pack contains 14, 56 or 196 hard capsules. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

Any unused product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands

Marketing authorization number(s)

EU/1/14/974/001 56 capsules EU/1/14/974/002 196 capsules EU/1/14/974/003 14 capsules

Date of first authorization / renewal of the authorization

Date of first authorisation: 19 January 2015

Πηγαίο έγγραφο

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