Resivisc® Hyaluronic Acid Fenix Pharma 3 Syringes of 2ml

Resivisc® Hyaluronic Acid Fenix Pharma

Hyaluronic acid sodium salt 2% for intra-articular use.

Resivisc is a sterile injectable, biodegradable and isotonic gel, for intra-articular use. consists of a medium molecular weight hyaluronic acid (1.0-1.5 x 106Dalton), produced by Streptococcus equi bacteria, formulated at a concentration of 20mg / ml in a physiological buffer. Resivisc is characterized by viscoelastic properties, therefore it helps to normalize the viscosity of the synovial fluid present in the intra-articular cavity.
Each pack contains one Resivisc vial-syringe and one package leaflet. There are two labels showing the lot number and the expiry 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.
Resivisc is a substitute for synovial fluid which, thanks to its viscoelastic and lubricating properties, favors the restoration of the rheological conditions of the joints, altered in case of degenerative or post-traumatic diseases. By improving the characteristics of the synovial fluid, the product 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.

How to use

Remove any joint effusion before injecting Resivisc; the same needle must be used for removal of the effusion and injection of Resivisc. Remove the protective cap of the syringe taking special care to avoid contact with the opening. Firmly screw the needle with a diameter between 18 and 22 Gal into the Luer type locking collar following the instructions below. Before injection treat the site with suitable disinfectant.
Inject using aseptic technique.
Inject into the joint cavity only.
It is advisable to carry out an initial cycle of three treatment sessions, at one week intervals from each other, possibly followed by maintenance sessions, according to the medical prescription.
Instructions for assembling the needle onto 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 guard and mount the needle onto the u-lock attachment, screwing firmly until a slight back pressure is felt to ensure a watertight seal and prevent the gel from escaping during administration.

Components

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

Warnings

Resivisc is indicated for intra-articular injections only 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 expiration date. Do not use the product if the packaging is already open or damaged. Do not use after the expiration date. Do not use needles other than those indicated. After the intra-articular injection, it is recommended that the patient avoid physical activities that are demanding for the joint and resume normal activities after a couple of days. Resivisc is a single use product, quality and sterility are only guaranteed if the syringe is sealed. Any residue must therefore be disposed of and not reused even following new sterilization. The syringe complete with needle should be discarded immediately after use, even if the solution has not been fully administered. After use, eliminate according to the regulations in force.
Incompatibilities: Incompatibilities exist 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 following the injection of Resivisc, such as pain, stiffness, warmth, redness or swelling. These secondary manifestations can be alleviated by applying ice to the treated joint. They usually disappear after a short time. If symptoms persist, seek medical attention. Any other unwanted side effects associated with Resivisc injection should be reported to your doctor.
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 conditions of the skin near the site of infiltration. 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 non-pyrogenic gel, sterilized with moist heat.