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HEALTHCARE PROFESSIONALS

iAluRil® (sodium hyaluronate, sodium chondroitin sulphate and calcium chloride) 50ml Pre-filled syringe with Luer-Lock Adaptor and Ialuadapter® Prescribing Information

Presentation: 50ml sterile solution of sodium hyaluronate (1.6% w/v – 800mg/50ml), sodium chondroitin sulphate (2% w/v – 1g/50ml) and calcium chloride (0.87% – 440mg/50ml) with a Luer-Lock adaptor and Ialuadapter®. Indications: Temporary re-establishment of glycosaminoglycans (GAGs) in the vesical urothelium in cases in which GAG loss can cause frequent and recurring problems (i.e. cystitis of varying etiology, chronic inflammation). Method of use: For intravesical instillation. Use with catheter: After patient urinates spontaneously, remove residual urine via catheter. Attach Luer-Lock adaptor to top of prefilled syringe and apply onto sterile catheter previously in place in bladder. Instil solution into bladder via catheter. Remove catheter and syringe and discard. Use with IAluadapter®: After patient urinates spontaneously, fasten IAluadapter® to top of prefilled syringe. Instil solution into bladder through IAluadapter®. Remove IAluadapter® and syringe and discard. For both methods of administration retain iAluRil in bladder for minimum of 30 minutes. Dosage: One bladder instillation of iAluRil 50ml per week for first month, one instillation every two weeks for second month and one instillation a month in following months until stable remission of symptoms or according to medical prescription. Contraindications: Patients with known hypersensitivity to any component. Legal category: Class III Medical Device. Cost: £88 for 50ml prefilled syringe with Luer-Lock adaptor and IAluadapter®. CE number: CE 0373 for prefilled syringe, CE 0482 for Luer-Lock adaptor and CE 1011 for iAluadapter®. Manufacturer: IBSA FARMACEUTICI ITALIA SRL, Via Martiri di Cefalonia, 2 26900 Lodi (LO), Italy. Distributor: Aspire Pharma Ltd, Unit 4, Rotherbrook Court, Bedford Road, Petersfield, Hampshire GU32 3QG, UK. Date reviewed: October 2018. Version number: 1010244269 v 2.0

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For further information please call: 01730 231148,
email: info@aspirepharma.co.uk or visit www.aspirepharma.co.uk

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard.
Adverse events should also be reported to Aspire Pharma Ltd on 01730 231148
Revision reference – iAluRil_4__16/09/2019