VELPHORO sucroferric oxyhydroxide 2500 mg (equivalent to iron 500 mg) chewable tablet blister

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

sucroferric oxyhydroxide, Quantity: 2500 mg

Tilgængelig fra:

Seqirus Pty Ltd

INN (International Name):

sucroferric oxyhydroxide

Lægemiddelform:

Tablet, chewable

Sammensætning:

Excipient Ingredients: colloidal anhydrous silica; neohesperidin-dihydrochalcone; magnesium stearate; Flavour

Indgivelsesvej:

Oral

Enheder i pakken:

30 (as both sale and starter packs), 90

Recept type:

(S4) Prescription Only Medicine

Terapeutiske indikationer:

Velphoro is indicated for the control of serum phosphorus levels in adult patients with chronic kidney disease (CKD) on dialysis.

Produkt oversigt:

Visual Identification: VELPHORO chewable tablets are brown, round, flat faced tablets embossed with PA500 on one side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius

Autorisation status:

Licence status A

Autorisation dato:

2014-11-27

Indlægsseddel

Vifor Pharma Pty Ltd
Version 09
1
VELPHORO
® 500 MG CHEWABLE TABLETS_ _
_EACH CHEWABLE TABLET CONTAINS 500 MG IRON (EQUIVALENT TO 2500 MG _
_SUCROFERRIC OXYHYDROXIDE) _
CONSUMER MEDICINE INFORMATION
_ _
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about
VELPHORO.
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
this medicine against the
benefits they expect it will 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 VELPHORO IS
USED FOR
VELPHORO is used to control
the phosphorus levels in the
blood of patients with chronic
kidney disease (CKD) on
dialysis.
It contains 2.5 g of the active
substance sucroferric
oxyhydroxide which
corresponds to 500 mg iron.
This medicine belongs to a
group of drugs used when the
levels of phosphorus in blood
are too high (a condition called
hyperphosphataemia).
The active ingredient works by
binding phosphate from food in
the digestive tract. This reduces
how much is absorbed and the
levels of phosphorus in the
blood.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
Your doctor may have
prescribed it for another reason.
BEFORE YOU TAKE
VELPHORO
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF
YOU HAVE AN ALLERGY TO:
•
the active substance
sucroferric oxyhydroxide, or
to any of the other
ingredient(s) listed at the end
of this leaflet
•
any other similar medicines
Some of the symptoms of an
allergic reaction may 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
DO NOT TAKE THIS MEDICINE IF
YOU HAVE TOO MUCH IRON IN
YOUR BODY
(HAEMOCHROMATOSIS) OR ANY
OTHER PROBLEMS WITH THE IRON
LEVELS IN YOUR BODY.
DO NOT TAKE THIS MEDICINE A

Produktets egenskaber

_Velphoro _
_®_
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_Page 1/13 _
AUSTRALIAN PRODUCT INFORMATION - VELPHORO
® (SUCROFERRIC
OXYHYDROXIDE) CHEWABLE TABLETS
1.
NAME OF THE MEDICINE
Sucroferric oxyhydroxide
2.
QUALITATIVE AND QUANTITIATIVE COMPOSITION
Each Velphoro chewable tablet contains 500 mg iron, equivalent to 2500
mg sucroferric
oxyhydroxide.
The active ingredient sucroferric oxyhydroxide contains 750 mg sucrose
and 700 mg starches.
For the full list of excipients see
SECTION 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
Velphoro chewable tablets are brown, round, flat-faced, chewable
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 chronic
kidney disease (CKD) on dialysis.
4.2.
DOSE AND METHOD OF ADMINISTRATION
Tablets must be taken with meals, chewed and not swallowed whole. The
tablets may be
crushed as an aid to chewing.
Patients receiving Velphoro should adhere to their prescribed diets.
STARTING DOSE
The recommended starting dose of Velphoro is 1,500 mg iron per day (3
tablets). Velphoro is
for oral administration only and must be taken with meals.
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.
_Velphoro _
_®_
_ _
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_Page 2/13 _
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 to 2,000 mg iron per day (3 to 4 tablets).
If one or more doses are missed, the normal dose of the medication
should be resumed with the
next meal.
MAXIMUM TOLERATED DAILY DOSE
The maximum recommended dose is 3,000 mg iron (6 tablets) per day.
PAEDIATRIC POPULATION
The safety and efficacy of Velphoro in children below the age of 18
years has n