Calcium Resonium 99.934 % Powder for oral or rectal suspension

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

Calcium polystyrene sulphonate

から入手可能:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATCコード:

V03AE; V03AE01

INN（国際名）:

Calcium polystyrene sulphonate

投薬量:

99.934 percent weight/weight

医薬品形態:

Powder for oral/rectal suspension

処方タイプ:

Product subject to prescription which may be renewed (B)

治療領域:

Drugs for treatment of hyperkalemia and hyperphosphatemia; polystyrene sulfonate

認証ステータス:

Marketed

承認日:

1983-04-01

情報リーフレット

PACKAGE LEAFLET:
INFORMATION FOR THE USER
CALCIUM RESONIUM® 99.934% W/W POWDER FOR ORAL OR RECTAL SUSPENSION
calcium polystyrene sulfonate
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READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, nurse or
pharmacist.

This medicine is only for you. Do not pass it on to others. It may
harm them, even if their signs of
illness are the same as yours.

If you get any side effects, talk to your doctor, nurse or pharmacist.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Calcium Resonium is and what it is used for
2.
What you need to know before you are given Calcium Resonium
3.
How Calcium Resonium is given
4.
Possible side effects
5.
How to store Calcium Resonium
6.
Content of the pack and other information
1.
WHAT CALCIUM RESONIUM IS AND WHAT IT IS USED FOR
Calcium Resonium contains a medicine called calcium polystyrene
sulfonate.
This belongs to a group of medicines called ‘ion exchange resins’.
Calcium Resonium is used to treat something called
‘hyperkalaemia’. This is when there is too much
potassium in your blood. It works by removing this extra potassium to
bring your levels back to
normal. It is often given to people who have kidney problems and
people on dialysis.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN CALCIUM RESONIUM
DO NOT USE CALCIUM RESONIUM IF:
×
You are allergic (hypersensitive) to calcium polystyrene sulphonate or
any of the other
ingredients in this medicine (listed in section 6).
Signs of an allergic reaction include: a rash, swallowing or breathing
problems, swelling of your
lips, face, throat or tongue
×
You have been told that you have a low level of potassium in your
blood
×
You have been told you have problems that result in high levels of
calcium in your body such as

製品の特徴

Health Products Regulatory Authority
14 December 2023
CRN00DTSF
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Calcium Resonium 99.934 % Powder for oral or rectal suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Calcium polystyrene sulphonate 99.934 % w/w
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Powder for oral or rectal suspension.
A buff-coloured, fine powder for oral or rectal suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Calcium Resonium is an ion-exchange resin that is recommended for the
treatment of hyperkalaemia associated with anuria or
severe oliguria. It is also used to treat hyperkalaemia in patients
requiring acute dialysis and in patients on regular
haemodialysis or on prolonged peritoneal dialysis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dosage recommendations detailed below are a guide only; the
precise requirements should be decided on the basis of
regular serum electrolyte determinations.
_Adults, including the elderly_
Oral:
The usual dose is 15g, 3 to 4 times a day. The resin is given by mouth
in a little water, or it may be made into a paste with
some sweetened vehicle.
Administer Calcium Resonium at least 3 hours before or 3 hours after
other oral medications. For patients with gastroparesis, a
6-hour separation should be considered1 (see Section 4.4 and Section
4.5).
Rectal:
In cases where vomiting may make oral administration difficult, the
resin may be given rectally as a suspension of 30g resin in
100ml 2% methylcellulose 450 BP (medium viscosity) and 100ml of water,
as a daily retention enema. In the initial stages
administration by this route as well as orally may help to achieve a
more rapid lowering of the serum potassium level.
The enema should, if possible, be retained for at least nine hours,
then the colon should be irrigated to remove the resin. If
both routes are used initially it is probably unnecessary to continue
rectal administration once the oral resin reached the
rectum.
_Paed