SEVELAMER HYDROCHLORIDE WINTHROP sevelamer hydrochloride 800 mg tablet bottle

Šalis: Australija

kalba: anglų

Šaltinis: Department of Health (Therapeutic Goods Administration)

Veiklioji medžiaga:

sevelamer hydrochloride

Prieinama:

Sanofi-Aventis Australia Pty Ltd

INN (Tarptautinis Pavadinimas):

Sevelamer hydrochloride

Autorizacija statusas:

Registered

Pakuotės lapelis

SEVELAMER HYDROCHLORIDE WINTHROP
®
1
SEVELAMER
HYDROCHLORIDE
WINTHROP
®
_Sevelamer hydrochloride _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Sevelamer
Hydrochloride Winthrop. It does not
contain all the available information.
It does not take the place of talking to
your treating doctor or a trained
health care professional.
All medicines have risks and
benefits. Your treating doctor has
weighed the risks of you taking
Sevelamer Hydrochloride Winthrop
against the benefits this medicine is
expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
TREATING DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT SEVELAMER
HYDROCHLORIDE
WINTHROP IS USED FOR
The name of your medicine is
Sevelamer Hydrochloride Winthrop.
It contains the active ingredient
called sevelamer hydrochloride.
Sevelamer Hydrochloride Winthrop
is used to treat hyperphosphataemia,
a condition caused by too much
dietary phosphorus being retained in
your body due to a diseased kidney.
ASK YOUR TREATING DOCTOR IF YOU
HAVE ANY QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
_HOW IT WORKS _
Sevelamer Hydrochloride Winthrop
belongs to a class of medicines that
are called ion exchange resins.
Sevelamer Hydrochloride Winthrop
helps to remove excess phosphorus
that has built up in your body by
binding the phosphorus that is in the
food that you eat.
BEFORE YOU USE
SEVELAMER
HYDROCHLORIDE
WINTHROP
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE SEVELAMER
HYDROCHLORIDE WINTHROP IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
sevelamer hydrochloride
•
any of the ingredients listed at the
end of this leaflet.
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
•
skin rash, itching or hives
DO NOT TAKE SEVELAMER
HYDROCHLORIDE WINTHROP IF YOU
HAVE:
•
hypophosphatemia, a condition
wh

Prekės savybės

Property of the Sanofi group - strictly confidential
Sev-winthrop-ccdsv6-piv5-25feb20
Page 1
AUSTRALIAN PRODUCT INFORMATION – SEVELAMER
HYDROCHLORIDE WINTHROP (SEVELAMER HYDROCHLORIDE)
1
NAME OF THE MEDICINE
Sevelamer hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sevelamer Hydrochloride Winthrop 800 mg tablets contain 800 mg
sevelamer hydrochloride on
an anhydrous basis.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Film coated tablets.
Sevelamer Hydrochloride Winthrop tablets are oval off-white
film-coated tablets imprinted with
"ZTV 800" on one side and is blank on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Sevelamer Hydrochloride Winthrop 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
DOSE
_STARTING DOSE _
The recommended starting dose for patients not taking a phosphate
binder is 800 to 1600 mg
(Table 1), which can be administered as one to two Sevelamer
Hydrochloride Winthrop 800 mg
tablets with each meal based on serum phosphorus level.
Property of the Sanofi group - strictly confidential
Sev-winthrop-ccdsv6-piv5-25feb20
Page 2
TABLE 1 - STARTING DOSE FOR PATIENTS NOT TAKING A PHOSPHATE BINDER
SERUM PHOSPHORUS
SEVELAMER HYDROCHLORIDE WINTHROP 800 MG TABLETS
> 1.78 and < 2.42 mmol/L
1 tablet, three times daily with meals

2.42 and <2.91 mmol/L
2 tablets, three times daily with meals

2.91 mmol/L
2 tablets, three times daily with meals
When patients are converting from a calcium based phosphate binder,
Sevelamer Hydrochloride
Winthrop should be given in equivalent doses on a (mg to mg) weight
basis compared to the
patient’s previous calcium based phosphate binder (Table 2). Serum
phosphorus levels should be
closely monitored and the dose of Sevelamer Hydrochloride Winthrop
adjusted accordingly with
the goal of lowering serum phosphorus. Serum phosphorus should be
tested every 2 to 3 weeks
until a stable serum phospho