SEVELAMER HYDROCHLORIDE SANOFI sevelamer hydrochloride 800 mg tablet bottle

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Ingredient activ:

sevelamer hydrochloride

Disponibil de la:

Sanofi-Aventis Australia Pty Ltd

INN (nume internaţional):

Sevelamer hydrochloride

Statutul autorizaţiei:

Registered

Prospect

SEVELAMER HYDROCHLORIDE SANOFI
®
1
SEVELAMER
HYDROCHLORIDE
SANOFI
®
_Sevelamer hydrochloride _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Sevelamer
Hydrochloride Sanofi. 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 Sanofi 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 SANOFI IS
USED FOR
The name of your medicine is
Sevelamer Hydrochloride Sanofi. It
contains the active ingredient called
sevelamer hydrochloride.
Sevelamer Hydrochloride Sanofi 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 Sanofi
belongs to a class of medicines that are
called ion exchange resins.
Sevelamer Hydrochloride 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.
BEFORE YOU USE
SEVELAMER
HYDROCHLORIDE SANOFI
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE SEVELAMER HYDROCHLORIDE
SANOFI 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
SANOFI IF YOU HAVE:
•
HYPOPHOSPHATAEMIA, A CONDITION
WHERE YOU

Caracteristicilor produsului

PRODUCT INFORMATION
April 2016
sevelamer hydrochloride sanofi
sev-sanofi-ccdsv4-piv3-12apr16
1
PRODUCT INFORMATION
SEVELAMER HYDROCHLORIDE SANOFI
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 sanofi
sev-sanofi-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 Sanofi tablets contain 400 mg or 800 mg of the
active ingredient
sevelamer hydrochloride on an anhydrous basis. Sevelamer Hydrochloride
Sanofi 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 Sanofi 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
Sanofi
contains
sevelamer,
a
non-absorbed
phosphate bindi