Calcium Resonium powder

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Calcium polystyrene sulfonate

Dostupné z:

Lexon (UK) Ltd

ATC kód:

V03AE01

INN (Medzinárodný Name):

Calcium polystyrene sulfonate

Dávkovanie:

999mg/1gram

Forma lieku:

Powder for oral or rectal suspension

Spôsob podávania:

Rectal; Oral

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: 09020101; GTIN: 5037015023217

Príbalový leták

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

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Calcium Resonium 99.934% w/w Powder for Oral/Rectal Suspension
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each bottle contains 99.934% w/w of the active substance Calcium
Polystyrene
Sulfonate.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Powder for Oral/Rectal Suspension
Cream or light brown coloured, fine powder
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 dialysis and in
patients on
regular haemodialysis or on prolonged peritoneal dialysis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Calcium Resonium is for oral or rectal administration only.
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 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.
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
considered (see sections 4.4 & 4.5).
Rectal
This route should be reserved for the patient who is vomiting or who
has upper
gastrointestinal
tract
problems,
including
paralytic
ileus.
It
may
be
used
simultaneously with the oral route for more rapid initial results or
in patients with
gastroparesis, who have other orally administered medications that are
administered
within 6 hours of Calcium Resonium. 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