RENVELA sevelamer carbonate 800 mg tablet bottle
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
01-12-2017
Summary of Product characteristics
(SPC)
25-08-2017
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
sevelamer carbonate
Available from:
Sanofi-Aventis Australia Pty Ltd
INN (International Name):
sevelamer carbonate
Authorization status:
Registered
Patient Information leaflet
RENVELA
®
1
RENVELA
®
_Sevelamer carbonate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Renvela.
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 Renvela
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 RENVELA IS USED
FOR
Renvela 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.
Renvela 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 Renvela 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
RENVELA
_WHEN YOU MUST NOT TAKE _
_RENVELA _
DO NOT TAKE RENVELA 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 body
•
rash, itching or hives on the skin
Tell your doctor if you are
experiencing these symptoms.
DO NOT TAKE RENVELA IF YOU :
•
have hypophosphatemia, a
condition where you do not have
enough phosphorus in
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Summary of Product characteristics
PRODUCT INFORMATION
August 2017
Renvela - sevelamer carbonate
renvela-ccdsv4-piv3-21aug17
1
PRODUCT INFORMATION
RENVELA
NAME OF MEDICINE
AUSTRALIAN APPROVED NAME
Sevelamer carbonate
CHEMICAL STRUCTURE
The structure is presented in Figure 1. FIGURE 1 - STRUCTURE OF SEVELAMER CARBONATE
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
.
PRODUCT INFORMATION
August 2017
Renvela - sevelamer carbonate
renvela-ccdsv4-piv3-21aug17
2
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
Renvela 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 Renvela film-coated tablet contains 800 mg of sevelamer carbonate
on an anhydrous basis.
Renvela 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 Renvela sachet contains 1.6 g or 2.4 g of sevelamer carbonate for
oral suspension on an
anhydrous basis. Each
sachet of Renvela powder
contains the following
excipients: RB26
Genzyme N&A citrus cream FL PWD #24660 (PI-109424), propylene glycol
alginate, sodium
chloride, sucralose, and iron oxide yellow.
PHARMACOLOGY
PHARMACODYNAMICS
MECHANISM OF ACTION
Pa
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