Renvela

Land: New Zealand

Språk: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv ingrediens:

Sevelamer carbonate 2400mg

Tilgjengelig fra:

sanofi-aventis new zealand limited

INN (International Name):

Sevelamer carbonate 2400 mg

Dosering :

2.4 g

Legemiddelform:

Powder for oral suspension

Sammensetning:

Active: Sevelamer carbonate 2400mg Excipient: 'Natural and Artificial Citrus Cream' proprietary flavouring Iron oxide yellow Propylene glycol alginate Sodium chloride Sucralose

Resept typen:

Prescription

Produsert av:

Genzyme Ltd

Indikasjoner:

Renvela is indicated for the management of hyperphosphataemia in adult patients with stage 4 and 5 chronic kidney disease.

Produkt oppsummering:

Package - Contents - Shelf Life: Sachet, Opaque, foil lined heat sealed - 15 dose units - 36 months from date of manufacture stored at or below 25°C protect from moisture. Do not refrigerate. - Sachet, Opaque, foil lined heat sealed - 60 dose units - 36 months from date of manufacture stored at or below 25°C protect from moisture. Do not refrigerate. - Sachet, Opaque, foil lined heat sealed - 90 dose units - 36 months from date of manufacture stored at or below 25°C protect from moisture. Do not refrigerate.

Autorisasjon dato:

2014-06-05

Informasjon til brukeren

RENVELA
®
1
RENVELA
®
_Sevelamer carbonate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Renvela.
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 Renvela
against the benefits this medicine is
expected to 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 RENVELA IS USED
FOR
Renvela contains the active substance
sevelamer carbonate and is used to
treat hyperphosphatemia, a condition
caused by too much dietary
phosphorus being retained in your
body due to a diseased kidney.
Increased levels of serum phosphorus
can lead to hard deposits in your
body called calcification. These
deposits can stiffen your blood
vessels and make it harder for blood
to be pumped around the body.
Renvela helps to remove excess
phosphorus that has built up in your
body by binding the phosphorus that
is in the food that you eat.
Your doctor, however, may have
prescribed Renvela for another
purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU
.
This medicine is only available with
a doctor's prescription.
BEFORE YOU TAKE
RENVELA
_WHEN YOU MUST NOT TAKE _
_RENVELA _
DO NOT TAKE RENVELA IF YOU HAVE AN
ALLERGY TO:
•
any medicine containing
sevelamer carbonate (the active
ingredient)
•
any of the ingredients listed at
the end of this leaflet
•
any other similar medicine, such
as sevelamer hydrochloride.
Symptoms that may indicate an
allergic reaction 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.
Tell your doctor if you are
experiencing these symptoms.
DO NOT TAKE RENVELA IF YOU HAVE:
•
hypophosphatemia, a condition
where you do not have enough
phosphorus in

Preparatomtale

renvela-ccdsv8-dsv4-09apr20
Page 1
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
Renvela 800mg film coated tablet
Renvela 1.6g powder for oral suspension
Renvela 2.4g powder for oral suspension
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Renvela film-coated tablet contains 800 mg of sevelamer carbonate
on an anhydrous basis.
Each Renvela sachet contains 1.6 g or 2.4 g of sevelamer carbonate for
oral suspension on an
anhydrous basis.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Renvela film-coated tablets: white oval film-coated tablets imprinted
with “RENVELA 800” on
one side and are blank on the other side.
Renvela powder for oral suspension: pale yellow powder free from
foreign particles in a sachet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Renvela is indicated for the management of hyperphosphataemia in adult
patients with stage 4 and
5 chronic kidney disease.
4.2
DOSE AND METHOD OF ADMINISTRATION
Renvela is available as tablets or powder for oral suspension.
renvela-ccdsv8-dsv4-09apr20
Page 2
Renvela
should
be
taken
in
conjunction
with
a
prescribed
diet
for
the
management
of
hyperphosphatemia.
Renvela 800 mg tablets must be taken three times per day with meals at
a dosage based on
individual patient requirements to control phosphate levels. Tablets
should be swallowed intact
and should not be crushed, chewed, or broken into pieces prior to
administration. Patients should
swallow the tablets whole with water.
Renvela 1.6 or 2.4 g powder sachet must be taken three times per day
with meals individually or
in combination at a dosage based on individual patient requirements to
control phosphate levels.
The powder should be dispersed in water (40 ml for 1.6 g powder sachet
and 60 ml for 2.4 g
powder sachet) prior to administration. Multiple sachets may be mixed
together, as long as the
appropriate amount of water is used. Patients should drink the
preparation within 30 minutes.
STARTING DOSE
The recommended starting dose of Renvela is 2.4 to 4.8 g per day base