Sevela Film-Coated Tablet 800mg

Country: Малезија

Језик: Енглески

Извор: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Активни састојак:

Sevelamer carbonate

Доступно од:

Asumed Biotech Sdn. Bhd.

INN (Међународно име):

Sevelamer carbonate

Јединице у пакету:

180 Tablets

Произведен од:

Chen Ho Pharmaceutical Co., Ltd. Sinying Plant

Информативни летак

_Consumer Medication Information Leaflet_ _(RiMUP) _
SEVELA FILM-COATED TABLET 800MG
_Sevelamer Carbonate 800mg _
_ _
_ _
1
WHAT IS IN THIS LEAFLET
a)
What Sevela is used for
b)
How Sevela works
c)
Before you use Sevela
d)
How to use Sevela
e)
While you are using it
f)
Side effects
g)
Storage and Disposal of Sevela
h)
Product Description
i)
Manufacturer and Product
Registration Holder
j)
Date of revision
k)
Serial Number
WHAT SEVELA
IS USED FOR
The name of your medicine is Sevela
Tablet 800mg (called “Sevela’ in this
leaftlet). Sevela contains a medicine
called Sevelamer Carbonate.
Sevela is a phosphate binder to be used
for the control of serum phosphorus in
adults receiving haemodialysis or
peritoneal dialysis, or with chronic
kidney disease not on dialysis with
serum phosphorus ≥ 1.78 mmol/l. Sevela
should be used within the context of a
multiple therapeutic approach, which
could include calcium supplement, 1,25-
dihydroxy Vitamin D3 or one of its
analogues to control the development of
renal bone disease.
HOW SEVELA WORKS
Sevela is a prescription medication
containing Sevelamer carbonate. It binds
phosphate from food in the digestive
tract and so reduces serum phosphorus
levels in the bloods.
BEFORE YOU USE SEVELA
WHEN YOU MUST NOT USE IT:
Do not use this product if you have
bowel obstruction or you are allergic to
_ _
sevelamer carbonate, sevelamer
hydrochloride, or any other ingredients
in this medication. (Please refer to
product description)
PREGNANCY AND LACTATION
Do not take Sevela if you are pregnant,
trying to get pregnant or think you may
be pregnant.
Do not take Sevela if you are breast-
feeding. Ask your doctor or pharmacist
for advice before taking any medicine.
_ _
BEFORE YOU START USE IT:
Before taking Sevela your doctor needs
to know if you have any other medical
condition that you may have, including
swallowing problems, problems with
motility (movement) in your stomach
and bowel, being sick frequently, active
inflammation of the bowel, have
undergone major surgery on your
stomach or bow

Карактеристике производа

COMPOSITION
Each capsule contains:
Sevelamer Carbonate 800mg
PRODUCT DESCRIPTION
Off-white to white oval shaped film-coated tablet, “CH86”on
single side.
PHARMACODYNAMICS
Pharmacotherapeutic group: All other therapeutic products,
drugs for treatment of hyperkalemia and hyperphosphataemia.
ATC code: V03AE02.
_Mechanism of action _
Sevela contains sevelamer, a non-absorbed phosphate binding
crosslinked polymer, free of metal and calcium. Sevelamer
contains multiple amines separated by one carbon from the
polymer backbone which become protonated in the stomach.
These protonated amines bind negatively charged ions such as
dietary phosphate in the intestine.
_Pharmacodynamic effect _
By
binding
phosphate
in
the
gastrointestinal
tract
and
decreasing
absorption,
sevelamer
lowers
the
phosphorus
concentration
in
the
serum.
Regular
monitoring
of
serum
phosphorus
levels
is
always
necessary
during
phosphate
binder administration.
PHARMACOKINETICS
Pharmacokinetic
studies
have
not
been
carried
out
with
sevelamer
carbonate.
Sevelamer
hydrochloride,
which
contains the same active moiety as sevelamer carbonate, is not
absorbed from the gastrointestinal tract.
In
addition,
the
potential
absorption
and
accumulation
of
sevelamer during long-term chronic treatment (> one year)
cannot be totally excluded.
INDICATION
Sevelamer
carbonate
is
indicated
for
the
control
of
hyperphosphataemia in adult patients receiving haemodialysis
or peritoneal dialysis.
Sevelamer
carbonate
is
also
indicated
for
the
control
of
hyperphosphataemia
in
adult
patients
with
chronic
kidney
disease not on dialysis with serum phosphorus ≥ 1.78 mmol/l.
Sevelamer carbonate should be used within the context of a
multiple therapeutic approach, which could include calcium
supplement,
1,25-dihydroxy
Vitamin
D3
or
one
of
its
analogues to control the development of renal bone disease.
RECOMMENDED DOSE
Because of the rapid disintegration of the carbonate salt tablet
and
its
rapid
reaction
with
the
hydrochloric
acid
in
the
stomach, the dosing of Sevelamer carbonate is