Pays: Israël
Langue: anglais
Source: Ministry of Health
POLYSTYRENE SULPHONATE SODIUM
SANOFI ISRAEL LTD
V03AE01
POWDER FOR SUSPENSION
POLYSTYRENE SULPHONATE SODIUM 99.934 %
PER OS, RECTAL
Required
SANOFI WINTHROP INDUSTRIE, FRANCE
POLYSTYRENE SULFONATE
POLYSTYRENE SULFONATE
Treatment of hyperkalemia.
2014-08-31
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 Lire le document complet
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 Lire le document complet