Where am I: Prescribing information & adverse events reporting
Prescribing information & adverse events reporting
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.
| 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 info@galen.co.uk. Medical information enquiries should also be directed to Galen Limited. |
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: info@galen.co.uk