Uracyst. A summary of the rationale and clinical evidence. Abbreviated Prescribing Information can be found on the last slide of this presentation. PMR-NOV-2010-0615 Date of Preparation: November 2010. . Uracyst . 2% solution of sodium chondroitin sulfate Medical device
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A summary of the rationale and clinical evidence
Abbreviated Prescribing Information can be found on the last slide of this presentation.
Date of Preparation: November 2010.
Fate of Texas Red labelled chondroitin sulfate after bladder damage with trypsin
* assessed by a Global Response Assessment (GRA) scale
View an interview with Dr Curtis Nickel
*Gepan Business Case, de Smit Medical
** Cystistat advertisement, Pliva
***iAluRil advertisement, Aspire Pharma
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2. Rosenberg M , Newman D and Page S. Interstitial cystitis/painful bladder syndrome: Symptom recognition is key to early identification, treatment. Cleveland Clinic Journal of Medicine. 2007; 74 (S3): S54-S62..
3. Hurst RE, Roy J and Parsons C. The role of Glycosaminoglycans in normal bladder physiology and the pathophysiology of interstitial cystitis. Interstitial Cystitis. 1997. Philadelphia. Lippincott-Raven Publishers.
4. Kelada E and Jones A. Interstitial cystitis. Arch Gynecol Obstet. 2007; 275:223-229.
5. Hurst RE et al. A deficit of proteoglycans on the bladder uroepithelium in interstitial cystitis. European Urology Supplements. 2 (2003) 10-13.
6. Hurst RE et al. Functional and structural characteristics of the glycosaminoglycans of the bladder luminal surface. The Journal of Urology. 1987; 138: 433-437.
7. Hurst RE et al. A deficit of chondroitin sulfate proteoglycans on the bladder uroepithelium in interstitial cystitis. Urology. 1996;48 (5); 817-821.
8. Kyker K, Coffman J and Hurst RE. Exogenous glycosaminoglycans coat damaged bladder surfaces in experimentally damaged mouse bladder. BMC Urology. 2005; 5:4
9. Hauser P et al. Restoring barrier function to acid damaged bladder by intravesical chondroitin sulfate. J Urol 2009; 182: 2477-2482.
10. Nickel JC et al. A real-life multicentre clinical practice study to evaluate the efficacy and safety of intravesical chondroitin sulphate for the treatment of interstitial cystitis. BJU International. Epub 3 September 2008.
11. Nickel JC et al. Chondroitin sulfate is a promising therapy for interstitial cystitis/painful bladder syndrome (IC/PBS). Abstract P114 presented at NAUA, October 2009. CUAJ 2009; 3(Suppl 3): S170.
12. Instillation of Uracyst Information Sheet. Stellar Pharmaceuticals Inc. September 2006.
13. Uracyst Package Insert. Stellar Pharmaceuticals. November 2008.
14. Interstitial cystitis and Uracyst Patient Information Booklet. Stellar Pharmaceuticals Inc.
The full Prescribing Information should be consulted prior to use.
Uracyst®Abbreviated Prescribing Information.
Description: Each ml of Uracyst contains 20mg sodium chondroitin sulfate (400mg of chondroitin sulfate per 20ml vial). Chondroitin sulfate is an acidic mucopolysaccharide and is one of the glycosaminoglycans (GAGs). The luminal surface of the bladder is coated with a layer of GAGs that provide a protective impermeable barrier to the bladder. Damage to this GAG layer may result in deficiencies to its protective barrier, inducing irritations in the bladder wall. Chondroitin sulfate is an important component of the bladder GAGs that can replenish the deficient GAG layer on the bladder epithelium.
Indications: For replenishment of the glycosaminoglycan (GAG) layer in the bladder, for patients with damaged or GAG deficient bladder epithelium.
Dosage and administration: Instil 20ml into the bladder after any residual urine has been removed. For optimum results, Uracyst should be used full strength without dilution, and retained in the bladder as long as possible (not less than 30 minutes). Repeat the instillation of 20ml weekly for 4 to 6 weeks, then, monthly thereafter until symptoms are relieved. Most patients benefit from 6 weekly 20ml instillations, then monthly instillations thereafter depending on their symptomatic response.
Contraindications: Do not administer to patients with known hypersensitivity to the solution.
Warnings: For Bladder Instillation only. Uracyst contains neither preservatives nor antimicrobials; therefore, any unused portion must be discarded.
Precautions: Bring the contents of vial to room temperature before use.
Adverse effects: No known adverse effects. Short-term discomfort may be caused by the catheterisation process.
Legal category: Medical device.
CE Number: CE 0473.
CE Mark Holder: Stellar Pharmaceuticals Inc, 544 Egerton Street, London, Ontario, Canada N5W 3Z8.
Package quantities and price: Single-dose glass vial of 20ml. Packages of four: £260 (UK), €300 (Ireland).
Storage: Store 2 to 25oC. Do not freeze. Discard unused portions. Distributed by: Galen Limited. Date of preparation: May 2009.
Galen Limited, Seagoe Industrial Estate, Craigavon, BT63 5UA. Galen Ireland, c/o Allphar Services Ltd, 4045 Kingswood Road, Citywest Business Park, Co Dublin, Ireland. Telephone: +44 (0) 28 3833 4974. Fax: +44 (0) 28 3839 1640. Website: www.galen.co.uk. Email: email@example.com.
Adverse incidents should be reported. Reporting forms and information can be found at www.mhra.gov.uk or www.imb.ie. Adverse incidents should also be reported to Galen Limited on +44 (0)28 3833 4974 and select the customer services option, or e-mail firstname.lastname@example.org. Medical information enquiries should also be directed to Galen Limited.