Intraject synovial fluid replacement agent 1.2% 2ml, 1pc

Composition

1. Sodium Hyaluronate

2. Phosphate buffer pH 7.4

The composition of dry matter, mg/ml (%):

– Sodium chloride 8.1 mg (81,0%) NaCL

, Potassium chloride 0.2 mg (2,00%) KCl

– Sodium phosphate disodium 12 water 1,45 mg (14,50%) Na2HPO4 x 12 N 2 O

– Potassium dihydrogen phosphate – 0.25 mg (2,50%) KH2PO4

3. Water for injection

Pharmacological action

Hyaluronic acid is a natural polysaccharide belonging to the class of glycosaminoglycans, which is part of all body tissues and is the most important structural element of synovial fluid. Hyaluronic acid is unmodified.

INTRAJECT® contains the

sodium salt of hyaluronic acid and water, whose molecules form hydrogen bonds due to the presence

of hydroxyl groups (OH groups) in the structure of the molecules, as well as the presence of a large number of oxygen and nitrogen atoms in the hyaluronic acid molecule. Due to the formation of hydrogen bonds with water molecules, hyaluronic acid has a high ability to bind and retain water, acquiring a jelly-like structure.

Macromolecules of hyaluronic acid form intramolecular and intermolecular interactions due to the same mechanisms, while giving a fairly stable three-dimensional structure.

The INTRAJECT ® product has an ordered gel structure that is able to hold hyaluronic acid and water molecules inside the synovial sac, ensuring the stability of the INTRAJECT® Product, which guarantees a prolonged action of the product.

Viscoelastic properties of hyaluronic acid, which is a part of synovial fluid, provide lubrication and cushioning of joint surfaces. Synovial fluid in the joints during degenerative diseases (osteoarthritis) or traumatic changes in the joints, has a lower viscosity and elasticity than in healthy joints. Hyaluronic acid, which is part of the INTRAJECT ® Product, has a molecular weight of 2.2 million daltons, close to the natural human hyaluronic acid, and has a positive effect after use in the diagnosis of osteoarthritis (osteoarthritis). Intra-articular injection of INTRAJECT® restores the physiological and rheological properties of the synovial fluid of the joint affected by osteoarthritis. As a result, pain and discomfort are reduced, and joint mobility is improved.

Indications

INTRAJECT® is intended for intra-articular use only.

INTRAJECT® is used:

1. For temporary replacement and replenishment of synovial fluid.

2. For the relief of pain and stiffness caused by degenerative-dystrophic (in osteoarthritis or osteoarthritis) and traumatic changes in the knee, hip and other synovial joints.

3. For use in patients who lead an active lifestyle and regularly load the damaged joint.

Use during pregnancy and lactation

There are no data on the safety of INTRAJECT® during pregnancy and lactation. Use

INTRAJECT® during pregnancy and lactation with caution and at the discretion of the attending physician.

Contraindications

1. Hypersensitivity or allergy to the components of INTRAJECT®.

2. The presence of a history of autoimmune diseases or autoimmune therapy.

3. Abnormal bleeding (endogenous or caused by the use of anticoagulants).

4. Infectious (septic) inflammatory process in the joint or periarticular tissues, intra-articular effusion, general infectious disease.

5. The presence of signs of active skin disease or skin infection in the immediate vicinity of the

injection site.

6. Pregnancy and lactation.

7. Children under 18 years of age.

Side effects

Intra-articular use of INTRAJECT ® is well tolerated. In rare cases, local secondary phenomena are possible: pain, a feeling of warmth, redness, swelling of the joint, the appearance of intra-articular exudation, extremely rare allergic reactions. Side effects may occur

immediately or after some time. These phenomena are short-lived and pass spontaneously. If these symptoms persist for more than one week, the patient should consult a doctor. In exceptional cases, septic arthritis may occur, including those not associated with the use of INTRAJECT®, the symptoms of this complication: the appearance of a local inflammatory reaction, increased joint pain, and an increase in body temperature.

Interaction

The effectiveness and safety of using INTRAJECT® in combination with simultaneous intra-

articular use of other medical devices and/or medicines has not been studied, so the combined use of INTRAJECT® with other medical devices and/or medicines is possible only if there is an evidence base for the safety and effectiveness of this method.

Incompatibility between sodium hyaluronate and quaternary ammonium salts, such as benzalkonium chloride, was noted. Therefore, in no case should INTRAJECT® be allowed to come into contact with such drugs or with medical and surgical instruments treated with such antiseptics.

How to take, course of use and dosage

Recommended course of use of INTRAJECT® in patients with moderate to moderate severity of osteoarthritis:

To gradually fill the synovial space of the joint, INTRAJECT® is administered in a course of 3 to 5 injections with a weekly interval between each injection.

The number of injections and the duration of the course of use is determined by the doctor, the recommended maximum duration of the course of use is no more than 6 weeks.

The break between INTRAJECT® use courses is determined by the doctor, the recommended break is from 6 to 12 months.

Simultaneous use of INTRAJECT® for several joints is possible.

The use of INTRAJECT® only affects the affected joint into which it is administered.

Description

INTRAJECT ® is a sterile, colorless, transparent, homogeneous, viscous gel without mechanical impurities obtained by bacterial fermentation.

INTRAJECT® does not contain animal proteins and does not require a preliminary allergy test.

Hyaluronic acid is a natural glycosaminoglycan of the intercellular matrix, which has the greatest hygroscopicity of all known natural mucopolysaccharides.

Special instructions

Please consult your doctor before using the medical device.

Please read the instructions for use carefully before using INTRAJECT®.

When preparing for use and when using the medical device itself, strict compliance with the rules of asepsis is required, since the risk of infection is possible.

Intravascular use of INTRAJECT® is unacceptable.

INTRAJECT® should not enter the joint capsule, surrounding tissues, or blood vessels.

Within 48-72 hours after the introduction of INTRAJECT® into the joint, it is not recommended to conduct physiotherapy, taping, compresses with medications, prolonged static tension on the limb, do not take a deep squat position, avoid running, jumping, or carrying heavy weights.

Storage conditions

Do not use the product with damaged packaging. Do not use after the expiration date. Keep out of reach of children.

Shelf

life is 3 years from the date of manufacture.

Active ingredient

Hyaluronic Acid

Dosage form

solution for injection