Cystistat (Sodium Hyaluronate)



Sodium Hyaluronate

GAG Layer Replacement

Action And Clinical Pharmacology: The glycosaminoglycan (GAG) layer on the luminal surface of the bladder wall is believed to provide a protective barrier against microorganisms, carcinogens, crystals and other agents present in the urine and has been identified as the primary defense mechanism in protecting the transitional epithelium from urinary irritants. Deficiencies in this GAG layer of the bladder epithelium may destroy its barrier function and allow the adherence of bacteria, microcrystals, proteins and ions, or the movement of ionic and nonionic solute residues (i.e., urea) across the epithelium. Hyaluronate has been developed to temporarily replenish the deficient GAG layer on the bladder epithelium. The active substance is a specific hyaluronic acid fraction of defined molecular chain length (combined average of 500 000 to 800 000 Daltons) with a high degree of purity.

Indications And Clinical Uses: Temporary replacement of the glycosaminoglycan (GAG) layer in the bladder.

Contra-Indications: At the present time there are no known contraindications to the use of sodium hyaluronate when used as recommended.

Precautions: Do not administer to patients with known hypersensitivity reactions.

Dosage: Instill the entire volume of one vial into the bladder after any residual urine has been removed. Discard any unused portion. For best results, Cystistat should be retained in the bladder for as long as possible (a minimum of 30 minutes). There is evidence that the GAG layer is deficient in conditions such as interstitial cystitis. In such situations, it is recommended that hyaluronate be instilled weekly for 4 treatments and then monthly until symptoms resolve.

Availability And Storage: Each vial contains: sodium hyaluronate 40 mg. Single use vials of 50 mL. Discard vial after use. Store at room temperature (15 to 30°C). Do not freeze.

CYSTISTAT® Bioniche Sodium Hyaluronate GAG Layer Replacement

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