Intraject 2.2% 2 ml

INTRAGEKT® is a sterile, colorless, transparent, homogeneous, viscous gel without mechanical impurities obtained by bacterial fermentation. INTRAGEKT® contains no animal proteins and does not require a prior allergy test. Hyaluronic acid is a natural glycosaminoglycan of intercellular matrix having the greatest hygroscopic properties of all known natural mucopolysaccharides.

Mechanism of action.

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

The product INTRAJECT® contains:

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

– in the molecular structure of hydroxyl groups (OH-groups), as well as the presence of a large number of nitrogen oxygen 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 gelatinous structure.

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

The INTRAGEKT® product has an ordered gel structure able to retain hyaluronic acid and water molecules inside the synovial pouch providing stability of the INTRAGEKT® product which guarantees its prolonged action.

The viscoelastic properties of hyaluronic acid, a component of synovial fluid, provide lubrication and cushioning of articular surfaces. Synovial fluid in the joints in degenerative diseases (osteoarthritis) or traumatic changes in the joints, has lower viscosity and elasticity than in healthy joints. Hyaluronic acid, a component of INTRAGEKT®, has a molecular weight of 2.2 million daltons, close to natural human hyaluronic acid, and has a positive effect after injection in the diagnosis of osteoarthritis (osteoarthritis). Intra-articular injection of INTRAJECT® restores physiological and rheological properties of synovial fluid of the joint affected by osteoarthritis. As a consequence, pain and discomfort decrease and mobility in the joints improves.

Biodegradation of the medical product in the patient’s body.

Complete biodegradation in the body occurs after 6 months. In the course of movement hyaluronates enter the lymphatic system of the joint capsule, enter the general bloodstream and are eventually absorbed by the liver where they degrade to water and carbon dioxide The product INTRAJECT® has no metabolic effects on the body. Once administered, INTRAJECT® should not be withdrawn or replaced.

Indications

INTRAJECT® is intended for intra-articular administration only.

INTRAJECT® is used:

1. For temporary replacement and replenishment of synovial fluid.

2. To relieve pain and stiffness caused by degenerative-dystrophic (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.

Pharmacological effect

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 tissues of the body and is the most important structural element of synovial fluid. Hyaluronic acid is unmodified.

INTRAJECT® product contains:

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

– in the structure of molecules of hydroxyl groups (OH-groups), 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, thanks to the same mechanisms, form intramolecular and intermolecular interactions, giving a fairly stable three-dimensional structure.

The INTRAJECT® product has an ordered gel structure, which is capable of retaining molecules of hyaluronic acid and water inside the synovial bursa, ensuring the stability of the INTRAJECT® product, which guarantees the prolonged action of the product.

The viscoelastic properties of hyaluronic acid, which is part of the synovial fluid, provide lubrication and shock absorption of the articular surfaces. Synovial fluid in joints with degenerative diseases (osteoarthritis) or traumatic changes in the joints has lower viscosity and elasticity than in healthy joints. Hyaluronic acid, which is part of INTRAJECT®, has a molecular weight of 2.2 million daltons, close to natural human hyaluronic acid, and has a positive effect after administration for a diagnosis of osteoarthritis (osteoarthritis). Intra-articular administration of INTRAJECT® restores the physiological and rheological properties of the synovial fluid of a joint affected by osteoarthritis. As a result, pain and discomfort are reduced and mobility in the joint 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 ultimately absorbed by the liver, where they are degraded to water and carbon dioxide. INTRAJECT® does not have a metabolic effect on the body. Once administered, INTRAJECT® cannot be removed or replaced.

Contraindications

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

2. A history of autoimmune diseases or undergoing autoimmune therapy.

3. Pathological 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. Presence of signs of active skin disease or skin infection in the immediate area

introduction.

6. Pregnancy and lactation.

7. Children under 18 years of age.

Side Effects

Intra-articular administration of INTRAJECT® is well tolerated. In rare cases, local secondary effects are possible: pain, sensation of warmth, redness, swelling of the joint, the appearance of intra-articular exudation, and extremely rarely allergic reactions.

Side effects may appear immediately or over time. These phenomena are short-term and disappear spontaneously. If these symptoms persist for more than one week, the patient should consult a doctor.

In exceptional cases, septic arthritis may occur, including that not associated with the use of INTRAJECT®; symptoms of this complication: the appearance of a local inflammatory reaction, increased pain in the joint, increased body temperature.

Interaction

The effectiveness and safety of using INTRAJECT® in combination with simultaneous intra-articular administration of other medical devices and/or drugs has not been studied, therefore the combined administration of INTRAJECT® with other medical devices and/or drugs is possible only if there is an evidence base for the safety and effectiveness of this method.

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

Manufacturer

FBK LLC, Russia