Description
CondronilIALDUE is a sterile, injectable, biodegradable, and isotonic gel for intra-articular use. CondronilIALDUE consists of medium molecular weight hyaluronic acid (1.0 – 1.5 / 106 Dalton), produced by Streptococcus equi bacteria, formulated at a concentration of 20 mg/ml in a physiological buffer.
CondronilIALDUE is characterized by viscoelastic properties, thus promoting the normalization of the viscosity of the synovial fluid present in the intra-articular cavity.
Each package contains one pre-filled syringe of CondronilIALDUE and an instruction leaflet. There are two labels indicating the lot number and expiration date. One of these labels must be applied to the patient's medical record and the other must be given to the patient to ensure traceability.
A synovial fluid substitute which, thanks to its viscoelastic and lubricating properties, promotes the restoration of the rheological conditions of the joints, altered in cases of degenerative or post-traumatic conditions.
The product, by improving the characteristics of the synovial fluid, exerts a protective action on the joints and promotes the improvement of 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 only for intra-articular injections and must be dispensed only by a physician who has received specific training on intra-articular injection technique.

Instructions for use
Remove any joint effusion before injecting CondronilIALDUE; the same needle should be used for effusion removal and CondronilIALDUE injection. Remove the protective cap from the syringe, taking particular care to avoid contact with the opening. Securely screw a needle with a diameter between 18 and 22 G onto the Luer-type locking collar, following the instructions below.
Before injection, treat the site with an appropriate disinfectant.
Inject CondronilIALDUE using an aseptic technique. Inject only into the joint cavity.
An initial course of three treatment sessions, at weekly intervals, is recommended, possibly followed by maintenance sessions, according to medical prescription.
INSTRUCTIONS FOR ATTACHING THE NEEDLE TO THE SYRINGE
A. Carefully unscrew the cap from the syringe tip, taking particular care to avoid contact with the opening.
B. Gently grasp the needle shield and mount the needle onto the Luer-lock fitting, screwing it firmly until a slight back pressure is felt 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. Infiltration should be avoided in the presence of ongoing infections or inflammatory skin conditions near the infiltration site. Since no clinical data are available on the use of hyaluronate in children, treatment with CondronilIALDUE is not recommended in these cases. It is advisable to recommend to the patient, after intra-articular injection, to avoid strenuous physical 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 disposed of and not reused, even after new sterilization.
Do not use the product if the packaging is already open or damaged.
The syringe with the needle must be disposed of immediately after use, even if the solution has not been completely administered. After use, dispose of according to current regulations.
Incompatibilities exist between sodium hyaluronate and quaternary ammonium compounds, such as benzalkonium chloride solutions. Therefore, avoid contact between CondronilIALDUE and these substances.
Some transient side reactions may occur following the injection of CondronilIALDUE, such as pain, stiffness, warmth, redness, or swelling. These secondary manifestations can be alleviated by applying ice to the treated joint. Normally, they 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 the doctor.
Keep out of reach of children.

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

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