Description
Pharmacological action
The product is intended for administration in order to replace synovial fluid in case of joint damage, to eliminate pain and improve joint mobility.
It is used for osteoarthritis and other degenerative, dystrophic, traumatic and post-traumatic changes in the joints: knee, hip and other large joints, as well as an aid in orthopedic surgery.
RIPART Synovial Fluid Replacement Agent is a sterile, pyrogen-free, colorless and transparent, viscous solution of highly purified sodium hyaluronate obtained by bio-fermentation. Sodium hyaluronate is the sodium salt of hyaluronic acid, glycosaminoglycan, formed by groups consisting of D – glucuronic acid and N – acetyl – D – glucosaminodisaccharide. It is widely represented in the extracellular matrix in both animals and humans.
Hyaluronic acid belongs to a small group of substances that are the same for all living organisms. Hyaluronic acid is a natural polysaccharide that is part of all body tissues, while in a particularly high concentration of hyaluronic acid is found in the synovial fluid and skin.
RIPART synovial fluid replacement product consists of a stabilized and purified hyaluronic acid produced in a biosynthetic manner. Hyaluronic acid in the body is a natural component of synovial fluid, which in the joints serves as a lubricant for cartilage and ligaments, and is also an absorber of shock loads.
It is known that synovial fluid in affected joints has lower viscosity and elasticity than synovial fluid in healthy joints. The introduction of hyaluronic acid into the joint in order to restore viscosity and elasticity can reduce pain and restore mobility in the joint. This medical device should only be used by specially trained personnel in medical facilities.
The product is supplied sterile.
Sterilization parameters: steam sterilization method in accordance with the requirements of GOST R ISO 11134-2000.
Product is pyrogen-free. Re-sterilizing the product is prohibited. Repeated use is prohibited.
Information for patients:
After intraarticular administration of the RIPART and RIPART Long synovial fluid replacement agent, passing pains and / or swelling of the joint into which the product was injected may occur.
As in the case of any invasive procedures performed on the joints, the patient is advised to avoid any physical exertion, as well as long-term (lasting more than 1 hour) activities related to carrying weight loads (this applies, for example, to jogging and tennis) within 48 hours after intra-articular administration of the drug.
Use in case of special patient groups:
Safety and efficacy of RIPART and RIPART Long synovial fluid replacement agents have not been established in pregnant women.
The safety and efficacy of the RIPART and RIPART Long synovial fluid replacement product for women during breast-feeding have not been established.
Safety and efficacy of RIPART and RIPART Long synovial fluid replacement in children have not been confirmed.
The period of preservation of the therapeutic effect and degradation of the medical device in the patient’s body. The protective film formed after the introduction of the medical product RIPART and RIPART Long retains its elasticity for 6 months.
After 6 months, the RIPART and RIPART Long medical device breaks down under the influence of a group of tissue enzymes called hyaluronidases into decomposition products: oligosaccharides and low molecular weight hyaluronates, which are subsequently excreted from the body.
Indications
It is used for osteoarthritis and other degenerative-dystrophic, traumatic and post-traumatic changes in the joints: knee, hip and other large joints, as well as an aid in orthopedic surgery.
Contraindications
It is forbidden to use in patients suffering from hypersensitivity (allergy) to sodium hyaluronate preparations.
It is forbidden to administer RIPART and RIPART Long synovial fluid to the joint of patients who have infections or skin diseases in the area where the injection is supposed to be performed.
Composition
Sodium hyaluronate at a concentration of 10 mg / ml, which is dissolved in physiological sodium – chloride – phosphate buffer solution (pH 6.8 – 7.5).
Side effects
Syrup for replacement of synovial fluid RIPART and RIPART Long is well tolerated.
Possible side effects include short-term passing pain at the injection site and swelling of the joint.
As a rule, such reactions pass without a trace within 2-3 days and in no way affect the effectiveness of treatment.
Cases of allergic and anaphylactic reactions are rarely mentioned.
If precautions are not taken during intra-articular administration, septic arthritis may occur in very rare cases.
active substance
Hyaluronate Sodium
pharmacy terms and conditions under the
