SEVELAMER CARBONATE WINTHROP sevelamer carbonate 2.4 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 WINTHROP
®
1
SEVELAMER CARBONATE
WINTHROP
®
_Sevelamer carbonate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Sevelamer Carbonate
Winthrop.
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 Winthrop 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 WINTHROP IS
USED FOR
Sevelamer Carbonate Winthrop
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 Winthrop 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
Winthrop 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
WINTHROP
_WHEN YOU MUST NOT TAKE _
_SEVELAMER CARBONATE _
_WINTHROP _
DO NOT TAKE SEVELAMER CARBONATE
WINTHROP 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
Read the complete document
Summary of Product characteristics
PRODUCT INFORMATION
Sevelamer Carbonate Winthrop - sevelamer carbonate
sevelamer-winthrop-ccdsv4-piv3-21aug17
1
PRODUCT INFORMATION
SEVELAMER CARBONATE WINTHROP
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 Winthrop - sevelamer carbonate
sevelamer-winthrop-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 Winthrop 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 Winthrop film-coated tablet contains 800 mg
of sevelamer carbonate
on an anhydrous basis. Sevelamer Carbonate Winthrop 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 Winthrop sachet contains 1.6 g or 2.4 g of
sevelamer carbonate for
oral suspension on an anhydrous basis. Each sachet of Sevelamer
Carbonate Winthrop powder
contains the following excipients: RB26 Genzyme N&A c
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