Velphoro® Chewable Tablets 500mg

Pays: Singapour

Langue: anglais

Source: HSA (Health Sciences Authority)

Ingrédients actifs:

sucroferric oxyhydroxide 2,500mg eqv iron

Disponible depuis:

FRESENIUS KABI (SINGAPORE) PTE LTD

Code ATC:

V03AE05

forme pharmaceutique:

TABLET, CHEWABLE

Composition:

sucroferric oxyhydroxide 2,500mg eqv iron 500 mg

Mode d'administration:

ORAL

Type d'ordonnance:

Prescription Only

Fabriqué par:

Catalent Germany Schorndorf GmbH

Statut de autorisation:

ACTIVE

Date de l'autorisation:

2015-01-29

Résumé des caractéristiques du produit

VELPHORO
®
1.
NAME OF THE MEDICINAL
PRODUCT
Velphoro
®
(sucroferric oxyhydroxide) chewable
tablet 500 mg iron.
2.
QUALITATIVE AND QUANTI­
TATIVE COMPOSITION
Each tablet of Velphoro contains sucroferric
oxyhydroxide corresponding to 500 mg iron.
The sucroferric oxyhydroxide contained in one
tablet is comprised of polynuclear iron (III)-oxyhy
-
droxide (containing 500 mg iron),750 mg sucrose
and 700 mg starches (potato starch and prege-
latinised maize starch).
For the full list of excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
Chewable tablet.
Red-brown, round, flat-faced tablets embossed
with PA500 on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Velphoro is indicated for the control of serum
phosphorus levels in adult patients with end-
stage renal disease (ESRD) on haemodialysis
or peritoneal dialysis.
4.2
POSOLOGY AND METHOD
OF ADMINISTRATION
Velphoro is for oral administration only.
POSOLOGY
STARTING DOSE
The recommended starting dose of Velphoro is
1,500 mg iron (3 tablets) per day administered as
1 tablet (500 mg iron) 3 times daily with meals.
TITRATION AND MAINTENANCE
Serum phosphorus levels must be monitored and
the dose of Velphoro up or down titrated in incre-
ments of 500 mg iron (1 tablet) per day as needed
every 1–2 weeks until an acceptable serum phos-
phorus level is reached, with regular monitoring
afterwards.
In clinical practice, treatment will be based on the
need to control serum phosphorus levels. In case
of hypophosphatemia occurring during the titra
-
tion and maintenance phase, Velphoro should be
down titrated to achieve appropriate serum phos
-
phorus levels.
Based on clinical studies, on average patients
required 1,500 mg iron to 2,000 mg iron (3 to 4 tab-
lets) a day to control serum phosphorus level.
If one or more doses are missed, the normal dose
of the medicinal product should be resumed with
the next meal.
MAXIMUM TOLERATED DAILY DOSE
The maximum recommended dose is 3,000 mg
iron (6 tablets).
SPECIAL POPULATIONS
PAEDIATRIC POPULATION
The safety and effica