HYALURONIC ACID SODIUM SALT 2.0% for INTRA-articular injection
DESCRIPTION JALOFIX40 is a sterile gel injectable, biodegradable and isotonic, for use in particular intra-ar. JALOFIX40 consists of an average molecular weight hyaluronic acid ( -1.5 1.0 x 106 daltons), produced by the bacteria Streptococcus equi, formulated at a concentration of 20 mg/ml with a physiological buffer.
JALOFIX40 is characterized by viscoelastic properties, thus allowing you to promote normalization of synovial fluid viscosity in intra-articular cavity. Each confection contains a vial-JALOFIX40 syringe and a leaflet. There are two labels bearing the batch number and expiration date. One of these labels must be applied on the patient’s medical record and the other should be handed over to the pa patient to ensure traceability.
JALOFIX40 is a substitute of synovial fluid which, thanks to its viscoe school and lubricants, helps restore rheological conditions of articulated tions, altered in case of posttraumatic or degenerative diseases.
The product performance characteristics of synovial fluid, exerts a protective effect on the joints and promotes improved joint function and reducing pain. JALOFIX40 acts only at the level of the joint that is injected, without exerting any systemic action.
Warnings-precautions for use: JALOFIX40 is only indicated for intraarticular injections and should be dispensed only by a physician who has received special training on intra-articular injection technique. Before use, check the integrity of the syringe and the expiration date. Do not use needles that are different from those indicated. The product should not be injected into an infected joint or severely inflamed.
Composition: sodium hyaluronate (20 mg/ml), sodium chloride, monobasic sodium phosphate dihydrate, know God hydrogen phosphate dodecahydrate, p.p.i. water directions:
Infiltration should be avoided in case of active infections or inflammatory conditions of the skin near the site of infiltration. Because there are no clinical data on the use of sodium hyaluronate in children, treatment with JALOFIX40 in these cases is not recommended. You should recommend to the patient, after the intra-articular injection, avoid strenuous physical activities for the articulation and resume normal activities after a couple of days.
JALOFIX40 is a disposable product, quality and sterility are guaranteed only if the syringe is sealed. Any residue must be disposed of and not reused even after new sterilization. Do not use this product if the packaging is opened or damaged. The needle should be discarded sirin ga full immediately after use, even if the solution has not been fully administered. After use discard in accordance with regulations.
Incompatibility: there are incompatibilities between the sodium hyaluronate and quaternary ammonium compounds, such as benzalkonium chloride solutions. Avoid contact between JALOFIX40 and these substances.
SIDE EFFECTS: there may be some transitional side reactions following injection of JALOFIX40, such as pain, stiffness, warmth, redness or swelling. These secondary manifestations can be relieved by applying ice cio on articulation. Normally disappear after a short ti me. If symptoms persist, seek medical attention. Any other unwanted side effects associated with the injection of JALOFIX40 must be referred to the doctor. How to use: remove any joint effusion before injecting JALOFIX40; for removal of the outpouring and the injection of JALOFIX40 must use the same needle. Remove the protective cap of the syringe carefully and pay special attention to avoid contact with the opening. Tighten the needle diameters between 18 and 22 G Luer-type locking collar by following the directions below. Before injection to treat the site with disinfectant.Inject JALOFIX40 adopting an apseptic technique. Inject only into the joint cavity. It is advisable to carry out an initial course of three treatment sessions, at one-week intervals from each other, followed possibly by sessions of maintenance, according to the prescription.
Assembly instructions of the needle on the SYRINGE carefully unscrew the CAP from the syringe tip, paying particular attention to avoid contact with the opening. 1) gently grasp the needle guard 2) and fit the needle into the luer-lock, screwing it tightly until you feel a slight pressure to ensure a watertight seal and prevent the escape of gel during administration.
STORAGE Store JALOFIX40 at 2 – 25° C (36 – 77° F) in a dry place in the original box. Protect from light, heat and frost. Keep out of reach of children.
PACKAGE CONTENTS: syringe containing 2 ml of gel non-pyrogenic, sterilized by moist heat.