SEVELAMER HYDROCHLORIDE WINTHROP sevelamer hydrochloride 400 mg tablet bottle

Quốc gia: Úc

Ngôn ngữ: Tiếng Anh

Nguồn: Department of Health (Therapeutic Goods Administration)

Thành phần hoạt chất:

sevelamer hydrochloride

Sẵn có từ:

Sanofi-Aventis Australia Pty Ltd

INN (Tên quốc tế):

Sevelamer hydrochloride

Tình trạng ủy quyền:

Registered

Tờ rơi thông tin

SEVELAMER HYDROCHLORIDE WINTHROP
®
1
SEVELAMER
HYDROCHLORIDE
WINTHROP
®
_Sevelamer hydrochloride _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Sevelamer
Hydrochloride Winthrop. It does not
contain all the available information.
It does not take the place of talking to
your treating physician or a trained
health care professional.
All medicines have risks and benefits.
Your treating physician has weighed
the risks of you taking Sevelamer
Hydrochloride Winthrop against the
benefits this medicine is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
TREATING PHYSICIAN OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT SEVELAMER
HYDROCHLORIDE
WINTHROP IS USED FOR
The name of your medicine is
Sevelamer Hydrochloride Winthrop.
It contains the active ingredient called
sevelamer hydrochloride.
Sevelamer Hydrochloride Winthrop is
used to treat hyperphosphataemia, a
condition caused by too much dietary
phosphorus being retained in your
body due to a diseased kidney.
ASK YOUR TREATING PHYSICIAN IF YOU
HAVE ANY QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
_HOW IT WORKS _
Sevelamer Hydrochloride Winthrop
belongs to a class of medicines that
are called ion exchange resins.
Sevelamer Hydrochloride 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.
BEFORE YOU USE
SEVELAMER
HYDROCHLORIDE
WINTHROP
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE SEVELAMER
HYDROCHLORIDE WINTHROP IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
sevelamer hydrochloride
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
skin rash, itching or hives
DO NOT TAKE SEVELAMER
HYDROCHLORIDE WINTHROP IF YOU
HAVE:
•
HYPOPHOSPHATAEMIA

Đặc tính sản phẩm

PRODUCT INFORMATION
April 2016
Sevelamer hydrochloride Winthrop
sev-winthrop-ccdsv4-piv3-12apr16
1
PRODUCT INFORMATION
SEVELAMER HYDROCHLORIDE WINTHROP
NAME OF MEDICINE
NON-PROPRIETARY NAME
Sevelamer hydrochloride.
CHEMICAL STRUCTURE
The structure is represented in Figure 1. FIGURE 1 - STRUCTURE OF SEVELAMER HYDROCHLORIDE
NH
2
•nHCl
NH•nHCl
OH
NH
2
•nHCl
NH•nHCl
C
A
M
B
a, b = number of primary amine groups
a + b = 9
c = number of crosslinking groups
c = 1
n = fraction of protonated amines
n = 0.4
m = large number to indicate extended polymer network
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
.
CAS REGISTRY NUMBER
152751-57-0.
PRODUCT INFORMATION
April 2016
Sevelamer hydrochloride Winthrop
sev-winthrop-ccdsv4-piv3-12apr16
2
DESCRIPTION
Sevelamer, or
poly(allylamine-co-N,N'-diallyl-1,3-diamino-2-hydroxypropane), a
cross-linked
polymer, is a white to off-white, water insoluble powder. Sevelamer is
a partial hydrochloride
salt, approximately 40% amine hydrochloride and 60% free base.
Sevelamer hydrochloride is
hydrophilic, but also insoluble in water.
Sevelamer Hydrochloride Winthrop tablets contain 400 mg or 800 mg of
the active ingredient
sevelamer hydrochloride on an anhydrous basis. Sevelamer Hydrochloride
Winthrop 400 mg and
800
mg
tablets
are
oval
film
coated
tablets
imprinted
with
“ZTV
400”
and
“ZTV
800”
respectively on the crown, on one side. The imprint contains iron
oxide black ink, propylene
glycol and isopropyl alcohol. The inactive ingredients in Sevelamer
Hydrochloride Winthrop
tablets are hypromellose, diacetylated monoglycerides, colloidal
anhydrous silica and stearic acid.
PHARMACOLOGY
PHARMACODYNAMICS
MECHANISM OF ACTION
Patients
with
end-stage
renal
disease
(ESRD)
retain
phosphorus
and
can
develop
hyperphosphataemia. Sevelamer Hydrochloride Winthrop contains
sevelamer, a non-ab