Description
Sterile solution of sodium hyaluronate (1.6%-800 mg/50 ml), sodium chondroitin sulfate (2%-1 g/50 ml), and calcium chloride (0.87%-440 mg/50 ml). For intravesical instillation.
The urothelium is covered by a layer of polyanionic molecules mainly composed of glycosaminoglycans (GAGs), a class of amino sugars that form an impermeable, protective, and neutralizing barrier against toxic and irritating substances present in urine (e.g., bacteria, microcrystals, proteins, ionic and non-ionic residues, etc.), preventing their systemic reabsorption. Among the GAGs that constitute the barrier, chondroitin sulfate and hyaluronic acid play a central role in the functioning of the barrier itself. Qualitative and quantitative variations at different levels of the two GAGs inactivate the barrier effect, leading to a series of conditions that can favor the onset of various types of cystitis (e.g., interstitial cystitis, recurrent cystitis caused by infections, cystitis induced by antineoplastic agents, radiation-induced cystitis, traumatic cystitis). Ialuril Prefill, a balanced combination of sodium hyaluronate, chondroitin sulfate, and calcium chloride, can functionally integrate into the barrier through the action of calcium chloride, restoring its protective function.
Ialuril Prefill is indicated for the restoration of glycosaminoglycan (GAG) layers of the bladder urothelium in cases where their loss can cause frequent and recurrent disorders (such as cystitis of various etiologies). Ialuril Prefill is also indicated in cases where the loss of glycosaminoglycan (GAG) layers is associated with forms of chronic inflammation, in which their composition and integrity appear variously compromised.
The Luer-Lock Adapter is sterilized with ethylene oxide.
Ialuadapter is sterilized with gamma rays.

Composition
Each 50 ml pre-filled syringe of Ialuril Prefill contains: water, calcium chloride, hyaluronic acid sodium salt, sodium chondroitin sulfate.

Instructions for use
· Frequency of use
It is recommended to instill the contents of 1 pre-filled syringe according to the following scheme:
-1 instillation per week for the first month;
-1 instillation every two weeks for the second month.
In subsequent months, 1 instillation per month is recommended until stable remission of symptoms is achieved, or according to medical indications.
· Instructions for use
Ialuril Prefill can be administered via catheter or Ialuadapter. The choice of administration method for each patient is made according to medical advice.
· Instructions for use with catheter
1. After the patient has spontaneously urinated, empty the bladder of any residual urine by inserting an appropriate sterile catheter through the external urethral meatus and wait for the complete outflow of urine collected in the bladder (at this stage, it is recommended to use an 8 Ch catheter).
2. Screw the plunger rod provided with the pre-filled syringe until it stops.
3. Mount the Luer-Lock Adapter on top of the pre-filled syringe and attach the sterile catheter previously placed in the bladder to it.
4. Slowly instill all the solution contained in the syringe into the bladder through the catheter.
5. When the product has been instilled into the bladder, carefully remove the catheter with the syringe and discard them.
6. Retain Ialuril Prefill in the bladder for as long as possible (minimum recommended time 30 minutes).
· Instructions for use with Ialuadapter
1. Before starting treatment, the patient is asked to urinate and ensure the bladder is completely empty before instillation.
2. Screw the plunger rod provided with the pre-filled syringe until it stops.
3. Attach the Ialuadapter to the top of the pre-filled syringe with a half-twist motion to achieve a stable fixation.
4. Slowly instill all the solution contained in the syringe into the bladder through the Ialuadapter.
5. When the product has been instilled into the bladder, carefully remove the Ialuadapter with the syringe and discard them.
6. Retain Ialuril Prefill in the bladder for as long as possible (minimum recommended time 30 minutes).

Warnings
The administration of Ialuril Prefill via catheter or Ialuadapter can only be performed by qualified personnel.
All operations must be carried out under controlled sterility and with gentleness because, for example, in the presence of interstitial cystitis, the patient:
-is particularly exposed to the onset of bacterial cystitis which exacerbates the symptoms of the ongoing pathology;
-experiences pelvic pain;
-urinates voluntarily less often to avoid aggravating pelvic pain triggered by the act of urination (muscle hypertonia induced by pain).
Wash hands thoroughly, if possible with detergent/antibacterial soap, and then wear sterile gloves before proceeding with the preparation and administration of Ialuril Prefill.
Strictly follow the operations suggested by the normal protocol for bladder instillation management.
Do not use Ialuril Prefill after the expiration date indicated on the package. Do not use the Luer-Lock Adapter if the package is open or damaged. Do not use the Ialuadapter if the package is open or damaged. Do not use Ialuril Prefill if the packaging is open or damaged. Do not use Ialuril Prefill if obvious impurities or precipitates are noticed in the product.
Do not re-sterilize. Ialuril Prefill is for single use only. Do not reuse unused portions of solution. Do not reuse to avoid any risk of contamination.
Keep out of reach and sight of children.
No interactions are currently known between Ialuril Prefill and medications normally used by patients with cystitis of various etiologies.
No contraindications are known to result from the use of Ialuril Prefill. Do not use Ialuril Prefill in case of known hypersensitivity to any of its components.
Ialuril Prefill is usually well tolerated. Occasionally, patients may experience local reactions (irritation, burning) due to the instillation procedure, not attributable to the Ialuril Prefill device. Discontinue treatment if any undesirable effect occurs.
Each pre-filled syringe is intended for a single patient.
Ialuril Prefill pre-filled syringe is heat sterilized. Ialuril Prefill pre-filled syringe is latex-free.
Administration can only be performed by a doctor or qualified personnel under the direct responsibility of the doctor.

Storage
Store between 0°C and 25°C and away from heat sources.
Once opened, Ialuril Prefill must be used immediately and disposed of after use.
Shelf life for intact packaging: 36 months.

Format
50 ml pre-filled syringe.
With Luer-Lock Adapter and Ialuadapter.

Code 16691