Device Dossier
IALURIL Prefill - Bladder instillation, barrier
Device Dossier for IALURIL Prefill - Bladder instillation, barrier (Bladder instillation, barrier, Class III, sponsor Juno Pharmaceuticals). ARTG record,…
- GMDN category: Bladder instillation, barrier
- Sponsor: Juno Pharmaceuticals
Intended purpose
iAluRil Prefill is indicated to re-establish the glycosaminoglycan layers (GAGs) of the urothelial vesical tissue in cases in which their loss can cause frequent and recurring problems such as Painful Bladder Syndrome (PBS), interstitial cystitis, treatment and prevention of recurrent urinary tract infection, cystitis as a result of Bacillus Calmette – Guerin therapy, or chemical and radiation therapy. iAluRil Prefill is also indicated in the cases where the loss of the glycosaminoglycan layers (GAGs) is associated with forms of chronic inflammation, in which their composition and integrity appears compromised in different ways.
Functional description
Clear plastic pre-filled syringe containing a sterile aqueous solution of hyaluronic acid sodium salt (1.6%), sodium chondroitin sulphate (2%) and calcium chloride administered as a bladder instillation via a catheter.