OSTEOVISC M 3ML / 60 MG – 90 MG
INTRA-ARTICULAR INJECTION OF HYALURONIC ACID AND CHONDROITIN SULFATE
INDICATIONS:
The product is indicated for viscoelastic supplementation or replacement of synovial fluid in human joints. The product is suitable for the treatment of symptoms of human joint disorders such as osteoarthritis.
PRODUCT DESCRIPTION:
The product is intended for the treatment of symptoms of human joint disorders such as osteoarthritis. Hyaluronic acid is a high molecular weight polysaccharide composed of sodium glucuronate and N-acetylglucosamine. Hyaluronic acid is distributed throughout all body tissues and is found in high concentrations in tissues such as vitreous, synovial fluid, umbilical cord, and dermis. Hyaluronic acid acts as a tissue lubricant and is thought to play an important role in regulating interactions between adjacent tissues. It also acts as a viscoelastic support that keeps tissues apart. Different hyaluronic acid preparations may have different molecular weights but are thought to have the same chemical structure. The average molecular weight of Hyaluronic acid in the product is 3 million daltons. Our product is non-inflammatory and well tolerated. Hyaluronic acid has been shown to be non-antigenic. The product does not interfere with normal wound healing processes.
COMPOSITION:
Sodium Hyaluronate, Chondroitin Sulfate, Sodium Chloride, Distilled water
USAGE:
Rule out possible joint e ffusion before injecting OSTEOVISC M. In case of joint effusion, aspiration, rest, ice application and/or intra-articular cortisone application are recommended to reduce the effusion. Product application begins after 2-3 days. The product is applied once a week for a total of 3 to 5 weeks. Several joints can be treated simultaneously. Depending on the severity of the disease, the effect of 5 intra-articular injections lasts for 6 months. A second cure can be applied if necessary. The duration of single application on the body is 35 days. The product content and the outer surface of the ready-to-use syringe are sterile until the package is opened. Remove the syringe from its packaging, following the instructions below. Remove the Luer-lock head. Apply a suitable disinfectant to the area before injection. Carefully insert the appropriate cannula (19-21G) by twisting it. Air bubbles must be removed before injection.
INSTRUCTIONS FOR ASSEMBLYING THE SYRINGE:
A. Carefully open the syringe tip cap, taking special care to avoid contact.
B.Carefully take the needle guard and mount it onto the luer-lock seat, screwing firmly until a slight counter-pressure is felt to ensure an airtight grip and prevent fluid from leaking during application.
WARNINGS-USE PRECAUTIONS:
Precautions normally taken when injecting substances into joints are recommended. Only medical professionals trained in accepted injection techniques for delivery into intra-articular synovial joint spaces should inject sodium hyaluronate for this application. Before use, the syringe integrity and expiration date should be checked. Needles other than those specified should not be used. The product should not be injected in the presence of an infected or severely inflamed joint. Infiltration should be avoided in case of active infection or inflammatory disease of the skin in the area close to the infiltration. Excessive amounts of sodium hyaluronate should not be used and the patient should be closely monitored. The area should not be overfilled. If pain increases during the injection procedure, the injection should be stopped and the needle withdrawn. Patients who experience abnormal sequelae of application of the product should consult a physician immediately. After intra-articular injection, it is important for the patient to avoid physical activities that are demanding on the joint and to resume normal activities after a few days.
ATTENTION:
The outer part of the packaging is not sterile. Since OSTEOVISC M has not been tested in pregnant or breastfeeding women, its use in such cases is not recommended. OSTEOVISC M should not be used in patients under 18 years of age. OSTEOVISC M is a single-use product; Its quality and sterility are only guaranteed if the syringe is closed. Therefore, the remaining part must be discarded and cannot be reused even after resterilization. Do not use the product if the packaging is opened or damaged. After use, dispose of the syringe in accordance with current legislation.
SIDE EFFECTS:
Some temporary side effects such as pain, stiffness, feeling of warmth, redness or swelling may occur after OSTEOVISC M injection. Such minor symptoms can be relieved by applying ice to the treated joint. Usually these effects disappear after a short time. If symptoms persist, consult a doctor. Other undesirable side effects related to OSTEOVISC M injection should be reported to a doctor. As with any intra-articular treatment, septic arthritis may occasionally occur when general precautions for injections are not taken or the injection site is not aseptic.
DISPUTE:
Incompatibility exists between sodium hyaluronate and quaternary ammonium compounds, such as benzalkonium chloride solutions. Therefore, avoid contact between OSTEOVISC M and these substances.
STORAGE CONDITIONS:
The products are stored at 05°C -24°C and low humidity (40-60% RH) before being sent to the customer. Excessive storage conditions, such as exposure to direct sunlight and/or storage on or near radiators, may damage the product.
PACKAGE INCLUDED:
Pre-frozen syringe containing 3 ml of non-pyrogenic gel.
