Calcium Resonium 99.934%w/w Powder for Oral or Rectal Suspension

Šalis: Malta

kalba: anglų

Šaltinis: Medicines Authority

Veiklioji medžiaga:

CALCIUM POLYSTYRENE, SULFONATE

Prieinama:

Sanofi S.R.L Viale L. Bodio, 37/b 20158, Milan, Italy

ATC kodas:

V03AE01

INN (Tarptautinis Pavadinimas):

CALCIUM POLYSTYRENE SULFONATE 99.934 % (W/W)

Vaisto forma:

POWDER FOR ORAL SUSPENSION POWDER FOR RECTAL SUSPENSION

Sudėtis:

CALCIUM POLYSTYRENE SULFONATE 99.934 % (W/W)

Recepto tipas:

POM

Gydymo sritis:

ALL OTHER THERAPEUTIC PRODUCTS

Autorizacija statusas:

Authorised

Leidimo data:

2007-08-20

Pakuotės lapelis

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Do not use this medicine if any of the above applies to you. If you
are not sure, talk to
your doctor, nurse or pharmacist before using Calcium Resonium.
TAKE SPECIAL CARE AND CHECK WITH YOUR DOCTOR, NURSE OR PHARMACIST
BEFORE
USING CALCIUM RESONIUM IF:
p It is for your baby, and they were premature, had a low birth-weight
or have reduced
gut movement
If you are not sure if any of the above apply to you, talk to your
doctor, nurse or
pharmacist before using Calcium Resonium.
TAKING OTHER MEDICINES
Please tell your doctor, nurse or pharmacist if you are taking or have
recently
taken any other medicines. This includes medicines you can buy without
prescription, including herbal medicines. This is because Calcium
Resonium can
affect the way other medicines work. Also some medicines can affect
the way Calcium
Resonium works.
In particular, check with your doctor if you are taking the following
medicines:
•
Medicines that contain salts such as magnesium, potassium or calcium.
Ask your
doctor if you are not sure
•
Some medicines for constipation (laxatives) that contain magnesium
•
Some medicines for indigestion (antacids) that contain magnesium or
aluminium
•
Digoxin or similar medicines from digitalis - for heart problems
•
Levothyroxine or thyroxine - for an under-active thyroid
•
Lithium - for mental illness
If you are not sure if any of the above applies to you, talk to your
doctor, nurse or
pharmacist before using Calcium Resonium.
PREGNANCY AND BREAST-FEEDING
Talk to your doctor before using this medicine if:
•
You are pregnant, might become pregnant, or think you may be pregnant
•
You are breast-feeding or planning to breast-feed
Ask your doctor or pharmacist for advice before taking any medicine.
3. HOW CALCIUM RESONIUM IS GIVEN
Your doctor or nurse will normally give you this medicine. If you are
not sure why you
are being given Calcium Resonium or have any questions about how much
Calcium
Resonium is being given to you, speak

Prekės savybės

1
NAME OF THE MEDICINAL PRODUCT
Calcium Resonium 99.934% w/w 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
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, 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 considered
1
(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.
Children:
Oral
1g/kg body weight daily in divided doses in acu