Intraject synovial fluid replacement agent 1.5% 2ml, 1pc

Composition

INTRAJECT®Product : 1. Sodium hyaluronate 2. Phosphate buffer pH 7.4 Dry matter composition, mg / ml (% ): – Sodium chloride – 8.1 mg (81.0%) NaCl – Potassium chloride – 0.2 mg (2.00%) KCl – Sodium phosphoric acid di – substituted 12 water 1.45 mg (14.50%) Na2HPO4 x 12 H2o-Potassium dihydrogen phosphate-0.25 mg (2.50%) KH2PO43. Water for injectingsprit: Syringe cylinder-Borosilicate glass, hydrolytic class I Lubricant-Silicone “Luer-Lock” adapter (for screw cap) – Polycarbonate elastic cap-Isoprene elastomer-Brombutyl plastic hard cap, piston finger rest-Polypropylene piston sealer elastic-Brombutyl elastomer Sterilization. The medical device is sterilized by steam method (autoclaving). Repeated sterilization is prohibited.

Pharmacological action

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. Mechanism of 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. The INTRAJECT® product contains in its composition: – the sodium salt of hyaluronic acid and water, the molecules of which 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. Biodegradation of a medical device in the patient’s body. Complete biodegradation in the body occurs after 6 months. During movements, hyaluronates enter the lymphatic system of the joint capsule, enter the general bloodstream, and are eventually absorbed by the liver, where they are degraded to water and carbon dioxide. INTRAJECT® does not have a metabolic effect on the body. After use, INTRAJECT® should not be removed or replaced.

Indications

INTRAJECT® is intended for intra-articular use only. INTRAJECT® is used: 1. For temporary replacement and replenishment of synovial fluid. 2. For 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.

Contraindications

1. Hypersensitivity or allergy to the components of INTRAJECT®.2. Having a history of autoimmune diseases or undergoing 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 efficacy 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.

Active ingredient

Hyaluronic Acid

Dosage form

solution for injection