Cerdelga

מדינה: האיחוד האירופי

שפה: אנגלית

מקור: EMA (European Medicines Agency)

מרכיב פעיל:

eliglustat

זמין מ:

Sanofi B.V.

קוד ATC:

A16AX10

INN (שם בינלאומי):

eliglustat

קבוצה תרפויטית:

Other alimentary tract and metabolism products,

איזור תרפויטי:

Gaucher Disease

סממני תרפויטית:

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).

leaflet_short:

Revision: 16

מצב אישור:

Authorised

תאריך אישור:

2015-01-19

עלון מידע

29
B. PACKAGE LEAFLET
30
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CERDELGA 84
MG HARD CAPSULES
eliglustat
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Cerdelga is and what it is used for
2.
What you need to know before you take Cerdelga
3.
How to take Cerdelga
4.
Possible side effects
5.
How to store Cerdelga
6.
Contents of the pack and other information
1.
WHAT CERDELGA IS AND WHAT IT IS USED FOR
Cerdelga contains the active substance eliglustat and 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 is
not effectively broken down by your body. As a result glucosylceramide
builds up in your spleen, liver
and bones. The build-up prevents these organs from working properly.
Cerdelga contains the active
substance eliglustat which decreases the production of
glucosylceramide, thereby preventing its build-
up. In turn this helps your affected organs to work better.
People differ in the speed that their body breaks down this medicine.
As a result the amount of this
medicine in the blood can differ between patients which could affect
how a patient would respond.
Cerdelga is meant to be used in patients whose body breaks down this
medicine at n

מאפייני מוצר

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Cerdelga 84 mg hard capsules
2.
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.
3.
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 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),
who are CYP2D6 poor metabolisers (PMs), intermediate metabolisers
(IMs) or extensive metabolisers
(EMs).
4.2
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 metabolisers (IMs)
and extensive metabolisers (EMs). The recommended dose is 84 mg
eliglustat once daily in CYP2D6
poor metabolisers (PMs).
_Missed dose _
If a dose is missed, the prescribed dose should be taken at the next
scheduled time; the next dose
should not be doubled.
Special populations
_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).
3
_ _
_Patients with hepatic impairment_
In CYP2D6 extensive metabolisers (EMs) with severe (Child-Pugh class
C) hepatic impairment,
eliglustat is contraindicated (see sections 4.3 and 5.