Cross-linked Sodium Hyaluronate

Instructions for Use

Read the manufacturer Instructions for Use completely and follow the instructions prior to use.

Contents

Each mL contains:

Sodium hyaluronate .............................................. 20 mg

Phosphate buffer saline, pH7.............................. q.s

Indications

Cross-linked Sodium Hyaluronate is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and to simple analgesics(e.g.acetaminophen)

Description

Cross-linked Sodium Hyaluronate contains 20 mg/mL of cross-linked nonanimal hyaluronic acid in buffered physiological sodium chloride solution pH7. Cross-inked Sodium Hyaluronate is a sterile, transparent viscoelastic gel supplied in a 3 mL glass syringe. The gel in the syringe has been sterilized by steam. The product is for single use only. 

Hyaluronic acid belongs to a group of very few substances which are identical in all living organisms. lt is a natural polysaccharide that is present throughout the tissues of the body, with particularly high concentrations in the synovial fluid and the skin. Cross-linked Sodium Hyaluronate is composed of biosynthetically produced hyaluronic acid which has been purified and stabilized. Cross-linked Sodium Hyaluronate is degraded in the body by the same metabolic pathway as endogenous hyaluronic acid.

Mode of Action

The body's hyaluronic acid constitutes a natural part of the synovial fluid and acts in the joints both as a lubricant of cartilage and ligaments and as a shock absorber, lt is known that the synovial fluid in joints affected by osteoarthritis has a much lower viscosity and elasticity than in healthy joints. injections of hyaluronic acid in the joint to restore the viscosity and elasticity can diminish the pain and improve the mobility of the joint.

Dosage

Cross-linked Sodium Hyaluronate is a single dose preparation and should only be injected once per treatment course. The recommended dose is 3 mL (one syringe) per knee joint.

Contraindications

None known.

Warnings

· Cross-linked Sodlum Hyaluronate should not be injected if the knee joint is infected or severely inflamed. 

· Cross-linked Sodium Hyaluronate should not be injected if there is an active skin disease or infection present at or near the injection site.

· Cross-linked Sodium Hyaluronate should not be injected intravascularly or extra-articularly or in the synovial tissues or capsule,

Precautions

· Cross-linked Sodium Hyaluronate should be used with caution in patients with venous or lymphatic stasis present in the leg.

· Cross-linked Sodium Hyaluronate has not been tested in pregnant or lactating women or in children.

· If treatment is bilateral, a separate syringe of Cross-linked Sodium Hyaluronate must be used for each knee.

· The pre-filled syringe is intended for single use. The contents of the syringe must be used immediately after opening the packaging. Discard any rest part of Cross-linked Sodium Hyaluronate. Reuse is possible to lead to some potential risks, e.g.Infection.

· Do not resterilize.

· Do not use if the blister package is in damaged condition, or if any cracks or breakage appears on the prefilled syringe.

· As with any invasive joint procedure there is a small risk of infection.

· Cross-linked Sodium Hyaluronate should not be injected if the patient is known to be sensitive to hyaluronic acid based products.

· Local anesthetics should not be used if the patient is known to be allergic or sensitive to local anesthetics.

· In clinical studies, reinjections in the knee have not been studied with a shorter interval between first and second injection than 6 months. The safety of overdosing has not been established.

· Cross-linked Sodium Hyaluronate should be used with caution in patients with pre-existing chondrocalcinosis as injection may lead to an acute attack of the condition.

· The used syringes and needles, or expired products should be disposed in compliance with pertinent government regulations regarding medical devices.

· The package contains a pre-printed implant card and a leaflet card, do not forget to complete it and give it to patient.

Adverse Events

The majority of the reported adverse reactions in clinical studies were described as transient pain. swelling and/or stiffness localized to the knee and were of mild or moderate intensity with a median duration of one week.

In a few patients symptoms of pain and/or swelling/stiffness localized to the knee lasted for more than 3 weeks but in these cases, the observed symptoms were not distinguishable from fluctuations in the underlying osteoarthritis condition. After injection, there are no necessary follow-ups, New and/or persistent side effects should be reported by the patient to the practitioner as soon as possible to remedy the problem using appropriate treatment. Adverse events must be reported to the manufacturer, distributor, EU authorized representative, and the competent authority.

Interactions

No information on the incompatibility of Cross-linked Sodium Hyaluronate with other products for intra-articular use is available to date.

Administration

General administration information

· Cross-linked Sodium Hyaluronate should only be injected by an authorized physician (or in accordance with local legislation) in facilities well suited for intra-articular injections.

· Cross-linked Sodium Hyaluronate should be injected using strict aseptic technique.

· The injection site should be swabbed with alcohol or other suitable antiseptic solution before injection.

· The route for injection with Cross-linked Sodium Hyaluronate should be chosen so that damage to adjacent vital structures is avoided.

.Cross-linked Sodium Hyaluronate should be injected into the joint cavity only.

· Remove joint effusion, if present, before injecting Cross-inked Sodium Hyaluronate. The same needles should be used for both removals of effusion and injection of Cross-linked Sodium Hyaluronate.

· The recommended needle size is 18 to 22 G and with adequate length.

Please Inform Your Patient that：

· As with any invasive joint procedure it is recommended to avoid strenuous activity (e.g.tennis, jogging or long walks) the first two days after the injection.

· Some transient reactions related to the injection of Cross-inked Sodium Hyaluronate, such as pain and/or swelling/stiffness of mild to moderate intensity during the first week following the injection can be anticipated, the symptoms last for more than a week a physician should be contacted

Performance

· Clinical data indicate significant mean benefits, such as improvement in knee pain and physical function versus baseline at 6 months post-treatment.

. Cross-linked Sodium Hyaluronate can degrade in the body and be gradually absorbed. Preclinical studies have shown that the product lasts in the body for more than six months.

How Supplied 

Cross-linked Sodium Hyaluronate is supplied in a 3 mL glass syringe with a Luer-lok fitting, packed in a blister pack. The contents of the syringe, stabilized non-animal hyaluronic acid gel, are sterile. Cross-linked Sodium Hyaluronate is intended for single use and should not be re-sterilized. it should be used immediately after the syringe has been removed from its packaging. lf the blister package or syringe is opened or damaged, do not use.

Storage

Cross-inked Sodium Hyaluronate should be stored at 5 ℃ to 30 ℃, in its original packaging. The expiry date is indicated on the package. Protect from freezing.

Shelf Life

2 years.

Specifications

3mL

8.18.04.0002-A0  lssued date: 2024-02-28