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

Dikeluarkan oleh:

Vifor SA

Risalah maklumat

_ _
_ _
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
VELPHORO CHEWABLE TABLET 500MG
Iron (as sucroferric oxyhydroxide) 500mg
_ _
1
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
li

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Velphoro PI Malaysia V3 – 14 July 2020
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1.
NAME OF THE MEDICINAL PRODUCT
Velphoro 500 mg chewable tablets
2.
PRODUCT DESCRIPTION
Each chewable tablet contains 500 mg iron as sucroferric oxyhydroxide
also known as a mixture of
polynuclear iron(III)-oxyhydroxide, sucrose, and starches.
The active ingredient sucroferric oxyhydroxide contains 750 mg sucrose
and 700 mg starches (potato
starch and pregelatinised maize starch) per tablet.
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