Land: Australien
Språk: engelska
Källa: Department of Health (Therapeutic Goods Administration)
eliglustat tartrate, Quantity: 100 mg (Equivalent: eliglustat, Qty 84.4 mg)
Sanofi-Aventis Australia Pty Ltd
eliglustat tartrate
Capsule, hard
Excipient Ingredients: lactose monohydrate; hypromellose; microcrystalline cellulose; glycerol dibehenate; iron oxide yellow; Gelatin; indigo carmine aluminium lake; titanium dioxide; mica; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; Shellac; sulfuric acid
Oral
56 capsules
(S4) Prescription Only Medicine
Cerdelga is indicated for the long-term treatment of adult patients with Gaucher disease type 1 (GD1).
Visual Identification: Pearl blue-green opaque cap and pearl white opaque body capsules with GZ02 printed in black on the capsule.; Container Type: Blister Pack; Container Material: PCTFE (Aclar)/AI; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2015-02-17
CERDELGA ® _eliglustat_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Cerdelga. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Cerdelga against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT CERDELGA IS USED FOR Cerdelga contains the active substance eliglustat. It belongs to a group of medicines that decrease the production of a substance called glucosylceramide in the body. Cerdelga is used for the long term treatment of adult patients with Gaucher disease type 1. Gaucher disease type 1 is a rare, inherited condition in which a substance called glucosylceramide builds up in the cells of your spleen, liver and bones. The build-up can prevent these organs from working properly. Cerdelga decreases the production of glucosylceramide, preventing its build-up. In turn this helps your affected organs to work better. Some people’s bodies break down this medicine faster than others. As a result the amount of this medicine in the blood can differ between patients which could affect how you will respond. Cerdelga is meant to be used in patients whose body breaks down this medicine at normal speed (known as intermediate metaboliser and extensive metaboliser) or slow speed (known as poor metaboliser). Your doctor will determine if Cerdelga is suitable for you before you start taking it, using a simple laboratory test. Gaucher disease type 1 is a lifelong condition and you must continue to take Cerdelga as prescribed by your doctor to gain the maximum benefit from your medicine. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor's prescription. There is not enough information to Läs hela dokumentet
PRODUCT INFORMATION Cerdelga - eliglustat AUSTRALIAN PRODUCT INFORMATION – CERDELGA (ELIGLUSTAT) 1 NAME OF THE MEDICINE Cerdelga (eliglustat) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Cerdelga capsule contains 84 mg eliglustat (equivalent to 100 mg eliglustat tartrate). For the full list of excipients, see Section 6.1- List of excipients. Eliglustat is a synthetic small molecule and is a white to off-white powder. Eliglustat tartrate is highly soluble in water. It has a pKa of 8.79 and log P of 2.84. 3 PHARMACEUTICAL FORM Cerdelga is formulated as a hard capsule for oral administration. Cerdelga is available as pearl blue-green opaque cap and pearl white opaque body capsules with “GZ02” printed in black on the capsule. The size of the capsule is ‘size 2’ (dimensions 18.0 x 6.4 mm). 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cerdelga is indicated for the long-term treatment of adult patients with Gaucher disease type 1 (GD1). 4.2 DOSE AND METHOD OF ADMINISTRATION Therapy with Cerdelga should be initiated and supervised by a physician knowledgeable in the management of Gaucher disease. Before initiation of treatment with eliglustat, patients should be genotyped for CYP2D6 to determine the CYP2D6 metaboliser status. Eliglustat can be taken with or without food. Avoid consumption of grapefruit or grapefruit juice with eliglustat because grapefruit is a strong CYP3A inhibitor. The capsules should be swallowed whole, preferably with water, and should not be crushed, dissolved, or opened. cer-ccdsv8-piv5-31may19 Page 1 of 22 PRODUCT INFORMATION Cerdelga - eliglustat If a dose is missed, the prescribed dose should be taken at the next scheduled time; the next dose should not be doubled. _CYP2D6 INTERMEDIATE METABOLISERS (IMS) AND EXTENSIVE METABOLISERS (EMS): _ The recommended dose of Cerdelga in CYP2D6 IMs and EMs is 84 mg twice daily taken orally. _IMPORTANT DOSING INFORMATION _ Co-administration of eliglustat with other CYP2D6 or CYP3A inhibitors affects its systemic exposure (see section 4.5 Läs hela dokumentet