Hyaluronic acid, sodium salt 2% for intra-articular use.
Resivisc is a sterile, injectable, biodegradable, and isotonic gel for intra-articular use. It consists of medium molecular weight hyaluronic acid (1.0-1.5 x 106 Daltons), produced by Streptococcus equi bacteria, formulated at a concentration of 20 mg/ml in a physiological buffer. Resivisc 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 Resivisc and an instruction leaflet. There are two labels showing the lot number and the expiry date. One of these labels should be applied to the patient's medical record and the other should be given to the patient to ensure traceability.
Resivisc is a synovial fluid substitute that, thanks to its viscoelastic and lubricating properties, promotes the restoration of the rheological conditions of the joints, which are 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. Resivisc acts only at the level of the joint where it is injected, without exerting any systemic action.

Instructions for use
Remove any joint effusion before injecting Resivisc; the same needle should be used for effusion removal and Resivisc injection. Remove the protective cap from the syringe, taking particular care to avoid contact with the opening. Securely screw the needle, with a diameter between 18 and 22 G, onto the Luer-lock collar following the instructions below. Before injection, treat the site with an appropriate disinfectant.
Inject using an aseptic technique.
Inject only into the joint cavity.
It is recommended to perform an initial cycle of three treatment sessions, at weekly intervals, possibly followed by maintenance sessions, according to medical prescription.
Instructions for assembling the needle on the syringe:
A. Carefully unscrew the cap from the tip of the syringe, 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 tightly 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
Resivisc is indicated only for intra-articular injections and should only be dispensed by a physician who has received specific training in intra-articular injection technique. Before use, check the integrity of the syringe and the expiry date. Do not use the product if the packaging is already open or damaged. Do not use after the expiry date. Do not use needles other than those indicated. 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. Resivisc 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. The complete syringe with 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: There are incompatibilities between sodium hyaluronate and quaternary ammonium compounds, such as benzalkonium chloride solutions. Therefore, avoid contact between these substances.
Side effects: Some transient side reactions may occur after Resivisc injection, 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 physician. Any other undesirable side effects associated with Resivisc injection should be reported to the physician.
Contraindications: The product should not be injected in the presence of an infected or severely inflamed joint. Infiltration should be avoided in case 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 Resivisc in these cases is not recommended.
Keep out of reach of children.

Storage
Store 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 by moist heat.