CondronilIALDUE

Description
CondronilIALDUE is a sterile, biodegradable, isotonic injectable gel for intra-articular use. CondronilIALDUE consists of a medium molecular weight hyaluronic acid (1.0–1.5 / 106 Daltons), produced by Streptococcus equi bacteria, formulated at a concentration of 20 mg/ml in a physiological buffer.
CondronilIALDUE is characterised by viscoelastic properties, therefore it helps to normalize the viscosity of the synovial fluid present in the intra-articular cavity.
Each package contains one vial of CondronilIALDUE syringe and a package insert. Two labels are included, indicating the batch number and expiration date. One label should be placed on the patient's medical record and the other should be given to the patient to ensure traceability.
A substitute for synovial fluid which, thanks to its viscoelastic and lubricating properties, promotes the restoration of the rheological conditions of the joints, altered in the case of degenerative or post-traumatic conditions.
By improving the characteristics of the synovial fluid, the product has a protective effect on the joints and promotes improved joint function and the reduction of painful symptoms.
CondronilIALDUE acts only at the level of the joint into which it is injected without exerting any systemic action.
Indicated for intra-articular injections only and should only be dispensed by a physician who has received specific training in the intra-articular injection technique.

How to use
Remove any joint effusion before injecting CondronilIALDUE; the same needle must be used for removing the effusion and injecting CondronilIALDUE. Remove the protective cap from the syringe, taking particular care to avoid contact with the opening. Securely screw the 18- to 22-gauge needle onto the Luer-type locking collar following the instructions below.
Before injecting, treat the site with a suitable disinfectant.
Inject CondronilIALDUE using aseptic technique. Inject only into the joint cavity.
It is recommended to carry out an initial cycle of three treatment sessions, at intervals of one week from each other, followed by maintenance sessions if necessary, according to the medical prescription.
INSTRUCTIONS FOR ASSEMBLING THE NEEDLE ON THE SYRINGE
A. Carefully unscrew the cap from the tip of the syringe, taking special care to avoid contact with the opening.
B. Gently grasp the needle shield and fit the needle onto the Luer-lock fitting, screwing firmly until you feel slight back pressure to ensure a watertight seal and prevent gel leakage during administration.

Components
Sodium hyaluronate (20 mg/ml), sodium chloride, sodium phosphate monobasic dihydrate, sodium phosphate dibasic dodecahydrate, water for injection

Warnings
Before use, check the integrity of the syringe and the expiration date. Do not use needles other than those indicated. The product should not be injected into an infected or severely inflamed joint. Injection should be avoided in cases of active infection or inflammatory conditions of the skin near the injection site. Since no clinical data are available on the use of hyaluronate in children, treatment with CondronilIALDUE is not recommended in these cases. Following the intra-articular injection, patients should be advised to avoid physically demanding activities for the joint and to resume normal activities after a couple of days.
CondronilIALDUE is a single-use product; quality and sterility are guaranteed only if the syringe is sealed. Any residue must therefore be discarded and not reused, even after re-sterilization.
Do not use the product if the packaging is already opened or damaged.
The syringe complete with needle must be discarded immediately after use, even if the solution has not been completely administered. After use, dispose of according to current regulations.
There are incompatibilities between sodium hyaluronate and quaternary ammonium compounds, such as benzalkonium chloride solutions. Therefore, avoid contact between CondronilIALDUE and these substances.
Some transient side effects may occur following the injection of CondronilIALDUE, such as pain, stiffness, warmth, redness, or swelling. These side effects can be relieved by applying ice to the treated joint. They usually disappear after a short time. If symptoms persist, consult a doctor. Any other unwanted side effects associated with the injection of CondronilIALDUE should be reported to your doctor.
Keep out of reach of children.

Conservation
Store CondronilIALDUE at 2-25°C (36-77°F) in a dry place in the original carton. Protect from light, heat, and frost.

Format
Pre-filled syringe containing 2 ml of pyrogen-free gel, sterilized by moist heat.