Velphoro Chewable Tablet 500mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Sucroferric Oxyhydroxide

Boleh didapati daripada:

FRESENIUS KABI MALAYSIA SDN. BHD

INN (Nama Antarabangsa):

Sucroferric Oxyhydroxide

Unit dalam pakej:

90 Tablets; 30 Tablets; 90 Tablets; 30 Tablets; 90 Tablets; 30 Tablets; 90 Tablets; 30 Tablets

Dikeluarkan oleh:

Vifor SA

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
CHEWABLE TABLET 500MG
VELPHORO
Iron (as sucroferric oxyhydroxide) 500mg
WHAT IS IN THIS LEAFLET
1.What Velphoro is used for
2.How Velphoro works
3.Before you use Velphoro
4.How to use Velphoro
5.While you are using it
6.Side effects
7.
Storage and Disposal of
Velphoro
8.
Product Description
9.Manufacturer and Product
Registration Holder 10.Date
of Revision
11. Serial number
1.
WHAT VELPHORO IS USED FOR
Velphoro is a medicine that
contains the active substance
sucroferric
oxyhydroxide,
which is made up from iron,
sugar (sucrose) and starches.
Velphoro is for use by adult
patients
who
undergo
haemodialysis
or
peritoneal
dialysis
(procedures
to
eliminate toxic substances from
the blood) because of chronic
kidney
disease;
it
is
used
in
order
to
help
control
the
phosphorus level in their blood
when
it
is
too
high
(hyperphosphataemia).
2.
HOW
VELPHORO
WORKS
Too much phosphorus in the
blood can lead to calcium being
deposited
in
tissues
(calcification). This can result
in
stiffening
of
the
blood
vessels, making
it
harder
for
the blood to be pumped around
the body. It may also lead to
calcium deposits in soft tissues
and bone causing effects such
as red eyes, itchy skin and bone
pain.
Velphoro
works
by
binding
phosphorus from food in your
digestive
tract
(stomach
and
intestines).
This
reduces
the
amount of phosphorus that can
be absorbed into the
bloodstream and thus lowers
phosphorus
levels
in
your
blood.
3.
BEFORE YOU USE VELPHORO
WHEN YOU MUST NOT USE IT:
-
if
you
are
allergic
to
sucroferric
oxyhydroxide
or
any of the other ingredients of
this medicine (listed in section
8)
-
if
you
have
a
history
of
abnormal iron build-up in your
organs (haemochromatosis)
-
if
you
have
any
other
disorder associated with too
much iron.
If you are not sure, talk to your
doctor
before
taking
this
medicine.
BEFORE YOU START TO USE IT
Talk
to
your
doctor
or
pharmacist
before
taking
Velphoro:
-
if you have had peritonitis, an
inflammation of the peritoneum
(the
thin
tissue
that
lines
the
in

Ciri produk

Velphoro PI Malaysia V3 – 03 Feb 2023
Page 1 / 9
.
NAME OF THE MEDICINAL PRODUCT
Velphoro 500 mg chewable tablets
2.
PRODUCT DESCRIPTION
Each chewable tablet contains sucroferric oxyhydroxide corresponding
to 500 mg iron.
The
sucroferric
oxyhydroxide
contained
in
one
tablet
is
comprised
of
polynuclear
iron(III)-
oxyhydroxide (containing 500 mg iron), 750 mg sucrose and 700 mg
starches (potato starch and
pregelatinised maize starch).
For the full list of excipients, see section 6.1.
Velphoro is provided in HDPE bottles containing 30 or 90 tablets,
packed in a single carton with a
package insert (see section 6.5).
3.
PHARMACEUTICAL FORM
Chewable tablet.
Brown, circular tablets embossed with PA500 on one side. Tablets have
a 20 mm diameter and a
thickness of 6.5 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Velphoro is indicated for the control of serum phosphorus levels in
adult chronic kidney disease
(CKD) patients on haemodialysis (HD) or peritoneal dialysis (PD).
Velphoro 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,
or calcimimetics to control
the development of renal bone disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Starting dose _
The recommended starting dose of Velphoro is 1,500 mg iron (3 tablets)
per day, divided across the
meals of the day. Velphoro is for oral administration only and must be
taken with meals.
Patients receiving Velphoro should adhere to their prescribed diets.
_Titration and maintenance _
Serum phosphorus levels must be monitored and the dose of Velphoro up
or down titrated in
increments of 500 mg iron (1 tablet) per day every 2-4 weeks until an
acceptable serum phosphorus
level is reached, with regular monitoring afterwards.
In clinical practice, treatment will be based on the need to control
serum phosphorus levels, though
patients who respond to Velphoro therapy usually achieve optimal serum
phosphorus levels at doses of
1,500 -2,000 mg iron p