SEVELAMER CARBONATE SANOFI sevelamer carbonate 1.6 g powder for oral suspension sachet
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
28-08-2017
Summary of Product characteristics
(SPC)
25-08-2017
Public Assessment Report
(PAR)
23-11-2017
Active ingredient:
sevelamer carbonate
Available from:
Sanofi-Aventis Australia Pty Ltd
INN (International Name):
sevelamer carbonate
Authorization status:
Registered
Patient Information leaflet
SEVELAMER CARBONATE SANOFI
®
1
SEVELAMER CARBONATE
SANOFI
®
_Sevelamer carbonate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Sevelamer Carbonate
Sanofi.
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 Sevelamer
Carbonate Sanofi against the benefits
this medicine is expected to have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET
. You may need to
read it again.
WHAT SEVELAMER
CARBONATE SANOFI IS
USED FOR
Sevelamer Carbonate Sanofi contains
the active substance sevelamer
carbonate and is used to treat
hyperphosphatemia, a condition
caused by too much dietary
phosphorus being retained in your
body due to a diseased kidney.
Increased levels of serum phosphorus
can lead to hard deposits in your
body called calcification. These
deposits can stiffen your blood
vessels and make it harder for blood
to be pumped around the body.
Sevelamer Carbonate Sanofi helps to
remove excess phosphorus that has
built up in your body by binding the
phosphorus that is in the food that
you eat.
Your doctor, however, may have
prescribed Sevelamer Carbonate
Sanofi for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU
.
This medicine is only available with
a doctor's prescription.
BEFORE YOU TAKE
SEVELAMER CARBONATE
SANOFI
_WHEN YOU MUST NOT TAKE _
_SEVELAMER CARBONATE SANOFI _
DO NOT TAKE SEVELAMER CARBONATE
SANOFI IF YOU HAVE AN ALLERGY TO:
•
any medicine containing
sevelamer carbonate (the active
ingredient)
•
any of the ingredients listed at
the end of this leaflet
•
any other similar medicine, such
as sevelamer hydrochloride.
Symptoms that may indicate an
allergic reaction include
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the bo
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Summary of Product characteristics
PRODUCT INFORMATION
Sevelamer Carbonate Sanofi - sevelamer carbonate
sevalamer-sanofi-ccdsv4-piv3-21aug17
1
PRODUCT INFORMATION
SEVELAMER CARBONATE SANOFI
NAME OF MEDICINE
AUSTRALIAN APPROVED NAME
Sevelamer carbonate
CHEMICAL STRUCTURE
The structure is presented in Figure 1. FIGURE 1 - STRUCTURE OF SEVELAMER CARBONATE
PRODUCT INFORMATION
Sevelamer Carbonate Sanofi - sevelamer carbonate
sevalamer-sanofi-ccdsv4-piv3-21aug17
2
The primary amine groups shown in the structure are derived directly
from poly (allylamine
hydrochloride). The cross - linking groups consist of two secondary
amine groups derived from
poly (allylamine hydrochloride) and one molecule of epichlorohydrin
.
Molecular Formula: (C
3
H
7
N.nH
2
CO
3
)
810z
(C
9
H
18
N
2
O.nH
2
CO
3
)
95z
where z = a large number
Chemical Name: poly (allylamine-
_co-N,N’_
-diallyl-1,3-diamino-2-hydroxypropane) carbonate salt.
CAS REGISTRY NUMBER
845273-93-0
DESCRIPTION
Sevelamer Carbonate Sanofi contains sevelamer, a non-absorbed
phosphate binding cross-linked
polymer, free of metal and calcium. Sevelamer is a white to off-white
powder comprising of a
partial carbonate salt with approximately 40 % amine carbonate and 60
% free base. Sevelamer
carbonate is amorphous, hygroscopic and hydrophilic, but insoluble in
water with a pH range of
8-10.5 as a 1% aqueous slurry.
Each Sevelamer Carbonate Sanofi film-coated tablet contains 800 mg of
sevelamer carbonate on
an
anhydrous
basis.
Sevelamer
Carbonate
Sanofi
tablets
contain
the
following
excipients:
microcrystalline cellulose, sodium chloride, purified water and zinc
stearate. The tablet coating
contains hypromellose and diacetylated monoglycerides. The tablet
printing ink also contains
hypromellose in addition to iron oxide black ink, propylene glycol,
isopropyl alcohol.
Each Sevelamer Carbonate Sanofi sachet contains 1.6 g or 2.4 g of
sevelamer carbonate for oral
suspension on an anhydrous basis. Each sachet of Sevelamer Carbonate
Sanofi powder contains
the following excipients: RB26 Genzyme N&A citrus cream FL PWD #2
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