Duralan implant viscoelastic sterile syringe, 3 ml

Hyaluronic acid belongs to a small group of substances that are the same in all living organisms. It is a natural polysaccharide that is part of all body tissues, with particularly high concentrations in synovial fluid and skin.

Duralan consists of biosynthetically produced stabilized and purified hyaluronic acid. Hyaluronic acid in the body is a natural constituent of synovial fluid, which in the joints serves as a lubricant for cartilage and ligaments, as well as an absorber of shock loads.

The synovial fluid in joints affected by osteoarthritis is known to have lower viscosity and elasticity than synovial fluid in healthy joints. Injecting hyaluronic acid into the joint to restore viscosity and elasticity can reduce pain and restore mobility in the joint.

Clinical studies show improvement in the patient’s condition with decreased pain in the knee joint and improved joint function compared to the initial condition at 6 months after injection. Repeated courses of treatment may be prescribed if necessary.

Clinical studies demonstrate an improvement in the patient’s condition with decreased pain in the hip joint and improved joint function compared to the baseline 6 months after injection.

Indications

For symptomatic treatment of mild to moderate osteoarthritis of the knee or hip.

Active ingredient

Composition

In 1 ml of the product contains:

Active ingredients:

Hyaluronic acid of non-animal origin, stabilized 20 mg.

Associates:

0.9% sodium chloride solution.

How to take, the dosage

Recommended dose: 3 ml (one syringe) per knee or hip joint.

A single injection of the drug is required per course of treatment.
Treatment of osteoarthritis of the hip joint

Intra-articular injection into the hip joint should be performed under X-ray control (preferably with the use of X-ray contrast agent) or under ultrasound control to ensure the correct position of the needle in the joint cavity.

The use of local anesthetics is recommended during needle insertion.

Injection into the hip joint should be performed by a physician experienced in this type of injection.

The recommended needle length is 130 mm #18-21.

Special Instructions

Duralan should be used with caution in patients with signs of impaired venous or lymphatic outflow in the lower extremities.

Duralan has not been studied in pregnant women or in children.

For bilateral treatment, separate syringes should be used for each knee or hip joint.

Do not use local anesthetics if the patient is known to be allergic or hypersensitive to local anesthetics.

Do not inject into the hip joint under radiological control using x-ray contrast agents if the patient is known to be allergic or hypersensitive to x-ray contrast agents.

General precautions for intraarticular injections should be observed.

DURALAN® administration should be performed only by a physician in a medical facility in a room equipped for intraarticular drug administration.

When administering the drug the aseptic rules should be strictly observed.

The injection site before injection should be treated with an alcohol swab or other appropriate antiseptic.

The access for the drug administration should be chosen in such a way as to avoid damage to the nearby vital structures. DURALAN® should only be injected into the joint cavity.

Prior to the administration of the drug the effusion from the joint, if any, must be removed. The same needle should be used to remove the effusion and administer DURALAN®.

We recommend the use of 18G to 22G needles of sufficient length.

The drug is intended for single use and should not be re-sterilized. It must be used immediately after removing the syringe from the package. If the blister pack or syringe is damaged, the drug must not be used.

Also, as with other invasive treatments, excessive exercise (playing tennis, running or long walks) should be avoided during the first two days after injection.

You can expect a transient reaction to the injection of the drug: pain and/or swelling, limitation of movement of mild to moderate severity during the first week after the injection. If these symptoms persist for more than one week, it is necessary to consult a physician.

Contraindications

With caution: in patients with signs of impaired venous or lymphatic outflow in the lower extremities.

Side effects

In the treatment of osteoarthritis of the knee: Transient pain, swelling, limitation of movement in the knee area.

The severity of side effects: mild to moderate with an average duration of one week.

In the treatment of osteoarthritis of the hip: aggravation of pre-existing pain syndrome, restriction of movement in the hip joint for up to 12 days.

Only a small number of patients need to use analgesics or NSAIDs.

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