KAYEXALATE

Land: Israel

Sprache: Englisch

Quelle: Ministry of Health

Wirkstoff:

POLYSTYRENE SULPHONATE SODIUM

Verfügbar ab:

SANOFI ISRAEL LTD

ATC-Code:

V03AE01

Darreichungsform:

POWDER FOR SUSPENSION

Zusammensetzung:

POLYSTYRENE SULPHONATE SODIUM 99.934 %

Verabreichungsweg:

PER OS, RECTAL

Verschreibungstyp:

Required

Hergestellt von:

SANOFI WINTHROP INDUSTRIE, FRANCE

Therapiegruppe:

POLYSTYRENE SULFONATE

Therapiebereich:

POLYSTYRENE SULFONATE

Anwendungsgebiete:

Treatment of hyperkalemia.

Berechtigungsdatum:

2014-08-31

Gebrauchsinformation

THERAPEUTIC GROUP: Medicines for the treatment of hyperkalaemia and
hyperphosphataemia.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
• You are sensitive (allergic) to the active ingredient sodium
polystyrene sulfonate
or to any of the other components of this medicine (see details in
section 6).
Signs of an allergic reaction include: rash, swallowing or breathing
problems,
swelling of the lips, face, throat or tongue.
• You have been told that you suffer from low blood potassium levels
(hypokalemia).
• Your gut is partially or completely blocked (obstructive bowel
disease).
• You are taking a sweetener called sorbitol (“no sugar”
sweetener). This is because
taking sorbitol and Kayexalate concomitantly may cause narrowing of
the
gut wall (gastrointestinal stenosis) and decreased blood flow to the
gut wall
(intestinal ischemia), which cause severe damage to the gut (necrosis
and
perforation). Do not take sorbitol during treatment with Kayexalate.
• Do not use in neonates with reduced gut motility (caused by
surgery or medicinal
treatment).
• Do not administer the medicine orally to neonates.
If one or more of the listed conditions apply to you, or if you are
uncertain, talk
to the doctor.
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
KAYEXALATE
POWDER
ACTIVE INGREDIENT AND ITS QUANTITY:
Sodium polystyrene sulfonate 99.934%
Inactive ingredients – see section 6.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THIS
MEDICINE. This leaflet
contains concise information about the medicine. If you have further
questions,
refer to the doctor or pharmacist.
Keep this leaflet; you may need to read it again.
This medicine has been prescribed to treat you. Do not pass it on to
others. It may
harm them even if it seems to you that their medical condition is
similar.
If a side effect worsens or if you experience a side effect not
mentioned in this
leaflet, please refer to a doctor

Fachinformation

1
_KAY-SPC-VER-6.0 _
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
KAYEXALATE
2
.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Contains Sodium Polystyrene Sulfonate 99.934% w/w.
Excipient with known effect:
Sodium 1,400 to 1,700 mg per 15g dose (see section 4.4).
For the full list of excipients, see section 6.1.
3
.
PHARMACEUTICAL FORM
Powder for oral and rectal suspension.
4
.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of hyperkalemia.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Sodium Polystyrene sulfonate is for oral or rectal administration
only.
The quantity of sodium polystyrene sulfonate to be administered is
directly related to the level of
potassium in the blood; it should therefore be adjusted to individual
patient needs.
_As a guide: _
_ _
In adults
_Oral route: _
A dosage of 15 g, or 1 measuring-spoonful or 4 level teaspoonfuls,
once to four times a day by
oromucosal use, is commonly prescribed. Sodium polystyrene sulfonate
is administered after
being put in suspension in a little water. Patients may decide to add
a little fruit syrup to the
water. Suspension in fruit juice is not allowed, because of the
latter's high potassium content.
2
Administer Kayexalate 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 route: _
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 Kayexalate.
Sodium polystyrene sulfonate can be administered in an enema after
being put in suspension in
100 ml of 10% dextrose solution at body temperature, or after mixing
equal proportions of water
and a 2% methylcellulose suspension.
The liquid containing the sodium polystyrene sulfonate in susp