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iAluRil Pre-fill

Sterile solution of sodium hyaluronate (1.6% - 800 mg/50 mL) and sodium chondroitin sulphate (2% - 1 g /50 mL)

50 mL pre-filled syringe for intravesical instillation

Product description

The urothelium is covered by a layer of polyanionic molecules mainly made up of glycosaminoglycans (GAGs). This is a class of aminosugars which form an impermeable, protective and neutralizing barrier against the toxic and irritating substances present in urine (e.g. bacteria, microcrystals, proteins, ionic and non-ionic residue etc.), preventing them from being reabsorbed at systemic level. Of the GAGs that form this barrier, chondroitin sulphate and hyaluronic acid play a central role in its functioning.

Qualitative and quantitative variations at various levels of the two GAGs deactivate the barrier effect, causing a series of conditions which can foster the onset of cystitises of various kinds (e.g. interstitial cystitis, recurring cystitises caused by infections, cystitises induced by antitumoral agents, cystitises induced by radiation, traumatic cystitises). iAluRil® Prefill, a balanced association of sodium hyaluronate, chondroitin sulphate and calcium chloride, can be functionally integrated into the barrier thanks to the action of the calcium chloride, re-establishing its protective function.

Indications

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, for example, cystitis of varying etiology.

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.

Composition

Each 50 ml pre-filled syringe of iAluRil® Prefill contains: water, calcium chloride, hyaluronic acid sodium salt, sodium chondroitin sulphate.

Frequency of use

The contents of one syringe should be instilled according to the following plan:

1 instillation a week the first month

1 instillation every two weeks the second month

In the following months, 1 instillation a month until the stable remission of the symptoms is recommended,, or according to medical advice.

Instructions for use

iAluRil® Prefill can be administered with a catheter or iAluadapter®.
The choice of the method of administration for each patient is carried out according to medical advice.

Instructions for use of iAluRil® Prefill with a Catheter

1. After the patient has urinated spontaneously, empty the bladder of all traces of urine by inserting a suitable sterile catheter through the external urethral meatus and wait for all the urine in the bladder to be evacuated (use of an 8 Ch catheter is recommended during this stage);

2. Screw the plunger rod supplied with the pre-filled syringe, until it is perfectly in place;

3. Mount the Luer-Lock Adapter on the top of the pre-filled syringe and apply onto it the sterile catheter previously placed in the bladder;

4. Slowly instil into the bladder all the solution contained in the syringe through the catheter;

5. When the product has been instilled into the bladder, carefully remove the catheter with the syringe and throw it away;

6. Keep iAluRil® Prefill in the bladder for as long as possible (minimum time recommended: 30 minutes).


Instructions for use of iAluRil® Prefill with a iAluadapter

1. Before starting the treatment, the patient is asked to urinate and to make sure to completely empty the bladder before the instillation.

2. Screw the plunger rod supplied with the pre-filled syringe, until it is perfectly in place;

3. Fasten the iAluadapter® on the top of the pre-filled syringe with a half twisting motion to achieve a stable attachment.

4. Slowly instil into the bladder all the solution contained in the syringe through the iAluadapter®;

5. When the product has been instilled into the bladder, carefully remove the iAluadapter® with the syringe and throw it away;

6. Keep iAluRil® Prefill in the bladder for as long as possible (minimum time recommended: 30 minutes).

Precautions for use

Administration of iAluRil® Prefill by catheter or by iAluadapter® may be carried out by medical practitioners, or may be self-administered after appropriate training. All the operations must be carried out in an appropriate environment and with care as, for example in the case of interstitial cystitis, the patient:

  • is particularly exposed to the onset of bacterial cystitises which may exacerbate the symptoms of the existing pathology
  • complains of pelvic pain
  • deliberately urinates less frequently in order not to aggravate the pelvic pain triggered off by the act of urination (muscular hypertone induced by pain).

Wash hands thoroughly preferably using an antibacterial/detergent and then wear sterile gloves before proceeding with the preparation and administration of iAluRil® Prefill.

Carefully follow the operations suggested by the normal protocol for intravesical instillations management.

Warnings

Do not use iAluRil® Prefill after the "use by" date shown on the packaging.

Do not use iAluRil® Prefill if the packaging is open or damaged. Do not use the Luer-Lock Adapter if the packaging is open or damaged.

Do not use the iAluadapter® if the packaging is open or damaged.

Do not use iAluRil® Prefill if there are visible impurities or precipitates in the product.

Do not sterilize again. iAluRil® Prefill is for use once only.

Do not reuse portions of unused solution.

Do not reuse to avoid any risk of contamination.

After opening, the device must be used immediately and disposed of after use.

Store at between 0° &and 25°C and far from sources of heat.

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Interactions

No interactions between iAluRil® Prefill and medicinal products normally used by patients with cystitises of varying etiology are known at the present time.

Contraindications

No contraindications deriving from the use of the device are known. Do not use iAluRil® Prefill in the case of known hypersensitivity to any of the components.

Side effects

iAluRil® Prefill is usually well tolerated and causes few, if any, adverse reactions.

Occasionally, patients could experience local reactions (irritation, burning) as a result of the instillation procedure itself, rather than from iAluRil® Prefill.

Suspend the treatment in the event of the onset of any undesired effect.

Additional Important Information

Each PRE-FILLED SYRINGE is for one patient only

iAluRil® Prefill - 50 mL pre-filled syringe is steam sterilised.

iAluRil® Prefill - 50 mL pre-filled syringe is latex free.

Luer-Lock Adapter is sterilised using ethylene oxide.

iAluadapter® is sterilized using Gamma ray.

The medical device must be administered to patients by medical practitioners or can be self-administered after appropriate training and under doctor control.

Shelf life: 36 months. The expiry date indicates the maximum validity of the medical device.

iAluRil ® Statement
iAluRil ® Statement
iAluRil ® Statement
iAluRil ® Statement
iAluRil ® Statement
GAG (glycosaminoglycan) layer: the barrier that protects the bladder lining from irritating and toxic substances found in urine.