Description
INTRAJECT Description.
INTRAJECT® is intended for intra-articular administration only and is used for:
– temporary replacement and replenishment of synovial fluid;
– reduction of pain syndrome and stiffness caused by degenerative-dystrophic (in osteoarthritis or osteoarthritis) and traumatic changes in joints, including the knee, hip, metacarpal, ankle, temporomandibular, facet, etc. by reducing friction in the damaged joint.
The application of INTRAJECT® is carried out by a specially trained specialist (rheumatologist or surgeon) in the conditions of special departments of medical and preventive institutions.
Field of application – orthopedics, rheumatology, traumatology, sports medicine.
Functional characteristics.
INTRAGEKT® product is sterile colorless clear 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, which has the greatest hygroscopicity of all known natural mucopolysaccharides.
Mechanism of action.
Hyaluronic acid is a natural polysaccharide that belongs to the class of glycosaminoglycans, which is a part of all body tissues and is the most important structural element of synovial fluid. Hyaluronic acid is unmodified.
The product INTRAJECT® contains the following components
sodium salt of hyaluronic acid and water, which 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 atoms of nitrogen in the molecule of hyaluronic acid. 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 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 that is able to retain hyaluronic acid and water molecules inside the synovial pouch, ensuring the stability of the INTRAGEKT® product, which guarantees the prolonged action of the product.
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 joint improves.
Biodegradation of the medical device in the patient’s body.
Full biodegradation in the body occurs after 6 months. During 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 Product INTRAJECT® has no metabolic effects on the body. Once administered, INTRAJECT® should not be withdrawn or replaced.
Pregnancy and lactation.
There are no data on the safety of INTRAGEKT® during pregnancy and lactation. The use of INTRAGEKT®
INTRAGEKT® during pregnancy and lactation – with caution and at the discretion of the attending physician.
Indications
The product INTRAJECT® is indicated for intraarticular administration only.
INTRAGEKT® is used for:
1. For temporary replacement and replenishment of synovial fluid. 2.
2. For relief of pain syndrome and stiffness caused by degenerative-dystrophic (osteoarthritis or osteoarthritis) and traumatic changes of knee, hip and other synovial joints. 3.
3. For use in patients who lead an active life and regularly load the damaged joint.
Contraindications
1. Hypersensitivity or allergy to components of INTRAJECT®. 2.
2. History of autoimmune disease or autoimmune therapy. 3.
3. Pathological bleeding (endogenous or caused by the use of anticoagulants).
Infectious (septic) inflammatory process in the joint or periarticular tissues, intraarticular effusion, general infectious disease. 5.
5. Presence of evidence 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.
How to use and doses
- Application of INTRAJECT® is carried out by specially trained specialist (rheumatologist or surgeon) in conditions of special departments of medical preventive institutions.
- The recommended course of INTRAGEKT® treatment is for patients with moderate to moderately severe osteoarthritis:
For gradual filling of the synovial space of the joint INTRAGEKT® is administered in a course of 3 to 5 injections with one week interval between each injection. - The number of injections and the duration of the course of administration is determined by the doctor, the recommended maximum duration of the course of administration is not more than 6 weeks.
- The interval between courses of injections of INTRAJECT® is determined by the doctor, the recommended interval being from 6 to 12 months.
Simultaneous use of INTRAGEKT® for several joints is possible. - Application of INTRAGEKT® has effect only on the affected joint in which it is injected.
- How to use.
Your physician should be consulted before using this product.
Before using the product INTRAJECT® , please read the instructions for use carefully.
During preparation for use and at the time of use of the medical product it is required to observe strict rules of asepsis. - The injection site should be thoroughly treated with an appropriate antiseptic and the skin should be allowed to dry prior to administration of the product.
- INTRAGEKT® is intended for intra-articular injections, the mode of administration depends on the severity of degenerative or traumatic changes in the joint and is determined by the attending physician. Injection into intravascular or extra-articular space as well as into synovial tissue or joint capsule is unacceptable.
- After storing INTRAGEKT® at temperatures below 15 °C, keep containers of INTRAGEKT® between 18 °C and 22 °C for 2 hours before use.
- The syringe is not supplied with needles. It is recommended to use disposable sterile needles from 19 to 21 G for INTRAGEKT® administration.
- Procedure for use of the INTRAGENT® in the syringe:
– Remove the blister from the carton pack;
– check that the blister is intact and undamaged;
– Remove the syringe from the blister;
– Prepare the syringe for use according to the recommendations above;
– Treat the area where INTRAGENT® is to be injected with disinfectant;
– Perform the injection.
