Resonium A powder

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Sodium polystyrene sulfonate

Available from:

Sanofi

ATC code:

V03AE01

INN (International Name):

Sodium polystyrene sulfonate

Dosage:

999.34mg/1gram

Pharmaceutical form:

Powder for oral or rectal suspension

Administration route:

Rectal; Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 09020101; GTIN: 5000283506874

Patient Information leaflet

CALCIUM RESONIUM 99.934% W/W POWDER FOR ORAL/
RECTAL SUSPENSION
(calcium polystyrene sulphonate)
For oral or rectal administration after reconstitution.
Calcium Cycle Ion Exchange Resin
Flavoured powder form of calcium polystyrene sulphonate for removing
excess potassium from the body.
YOUR MEDICINE CONTAINS 99.934% W/W OF CALCIUM POLYSTYRENE SULPHONATE
AS THE ACTIVE INGREDIENT.
One level measuring spoon contains 15g of Calcium Resonium.
Always read the leaflet attached before use and for details of dosage
regime. Use as directed by your doctor.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN. Store in a dry place. Do
not store above 25°C.
The suspension should be prepared immediately before use. Do not store
for longer than 24 hours after reconstitution.
Procured from within the EU and repackaged by the Product Licence
Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat,
Redditch, Worcestershire, B98 0RE. Manufactured by SANOFI-SYNTHELABO
LIMITED, Edgefield Avenue - Fawdon, Newcastle Upon Tyne
NE3 3TT United Kingdom. Calcium Resonium is a registered trademark of
Sanofi-Synthelabo Inc.
P
Ref: 1399/040215/CL/01
®
300G powder
Base Label 210mm
Front Cover 225mm
PEEL HERE
300G powder
CALCIUM RESONIUM 99.934% W/W POWDER FOR ORAL/
RECTAL SUSPENSION
(calcium polystyrene sulphonate)
For oral or rectal administration after reconstitution.
Calcium Cycle Ion Exchange Resin
Flavoured powder form of calcium polystyrene sulphonate for removing
excess potassium from the body.
YOUR MEDICINE CONTAINS 99.934% W/W OF CALCIUM POLYSTYRENE SULPHONATE
AS THE ACTIVE INGREDIENT.
One level measuring spoon contains 15g of Calcium Resonium.
Always read the leaflet attached before use and for details of dosage
regime. Use as directed by your doctor.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN. Store in a dry place. Do
not store above 25°C.
The suspension should be prepared immediately before use. Do not store
for longer than 24 hours after reconstitution.
Procured from within the EU and repackaged by the Product Licence
Holder

Summary of Product characteristics

OBJECT 1
RESONIUM A
Summary of Product Characteristics Updated 24-Jan-2014 | SANOFI
1. Name of the medicinal product
Resonium A.
2. Qualitative and quantitative composition
Contains Sodium Polystyrene Sulfonate 99.934% w/w.
3. Pharmaceutical form
Buff coloured powder.
4. Clinical particulars
4.1 Therapeutic indications
Resonium A 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 dialysis and in
patients on regular haemodialysis or on prolonged peritoneal dialysis.
4.2 Posology and method of administration
Resonium A is for oral or rectal administration only.
The dosage recommendations detailed in this section 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 three or four times a day. Each dose should be
given as a suspension in a small
amount of water or, for greater palatability, in syrup (but not fruit
juices which contain potassium), in the
ratio of 3 to 4ml per gram of resin.
Rectal
This route should be reserved for the patient who is vomiting or who
has upper gastrointestinal tract
problems, including paralytic ileus or it may be used simultaneously
with the oral route for more rapid
initial results. The resin may be given rectally as a suspension of
30g resin in 150ml of water or 10%
dextrose, 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
following which 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 has reached the rectum.
Children:
Oral
In smaller children and infants correspondingly smaller doses should
be employed by using as a guide a
rate of 1