Ripart synovial fluid replacement agent 10mg/ml 2ml syringe, 1pc

Composition

1 ml contains:

Sodium Hyaluronate 10 mg

Sodium Dihydrogen Phosphate 0.1 mg

Disodium hydrophosphate 0,6 mg

Sodium chloride, solution for infusions of 0.9% – up to a volume 1 ml

Characteristics

Synovial fluid replacement agent is a sterile, colorless and transparent viscous solution of highly purified sodium hyaluronate obtained by the biofermentation method. The product contains sodium hyaluronate at a concentration of 10 mg / ml of sodium dihydrogen phosphate, disodium hydrophosphate, sodium chloride 0.9% solution for infusions.

Sodium hyaluronate is the sodium salt of hyaluronic acid. It is widely present in the extracellular matrix in both animals and humans. The molecular weight of sodium hyaluronate used in the manufacture of synovial fluid replacement products should be at least 3 MDa.

Sodium hyaluronate belongs to a small group of substances that are the same for all living organisms. Sodium hyaluronate is a naturally occurring polysaccharide found in all body tissues, with particularly high concentrations of sodium hyaluronate found in synovial fluid and skin. Synovial fluid replacement agent consists of biosynthetically produced and purified sodium hyaluronate. Sodium hyaluronate in the body is a natural component of synovial fluid, which in joints serves as a lubricant for cartilage and ligaments, and is also a shock absorber. Synovial fluid in affected joints is known to have a lower viscosity and elasticity than synovial fluid in healthy joints. Injecting sodium hyaluronate into the joint to restore its viscosity and elasticity can reduce pain and restore mobility in the joint.

The composition of the synovial fluid replacement agent ensures the restoration of viscoelastic properties and the transition of the viscous properties of the solution to elastic (elastic) in the range of shear rates from 0.5 to 2.5 Hz, which corresponds to the range of movements from walking to running.

Indications

• Osteoarthritis and other degenerative-dystrophic, traumatic and post-traumatic changes in the joints: knee, hip and other joints.
• As an auxiliary tool in orthopedic surgery.
• For use in patients who have increased physical activity and regularly load the damaged joint.

Contraindications

• It is forbidden to use in patients suffering from hypersensitivity (allergy) to products containing sodium hyaluronate.
• It is forbidden to introduce a synovial fluid replacement agent into the joint of patients who have infectious or skin diseases in the area of the site where the injection is supposed to be performed.

Side effects

The synovial fluid replacement agent is well tolerated. Possible side effects include short-term passing pain at the injection site, a feeling of heat, bruising, redness, and / or swelling. As a rule, such reactions pass without a trace within 2-3 days and do not affect the effectiveness of treatment in any way. Cases of allergic and anaphylactic reactions are rare. In very rare cases, septic arthritis may occur if precautions are not taken for intra-articular use.

How to take, course of use and dosage

The amount of synovial fluid replacement administered depends on the size of the joint. It is the doctor’s responsibility to determine the applicable volume and make sure that the joint is not overloaded.

The course of treatment with RIPART ® synovial fluid replacement usually requires a cycle of procedures consisting of 3-5 injections (with an interval of 1 week).

The choice of dosage is at the discretion of the attending physician.

If necessary, the course can be repeated.

The decision on the applicability of the repeated course is made by the attending physician.

Procedure for working with a medical device

Inject the required amount of synovial Fluid Replacement into each joint. If there is a medical prescription that involves injecting into several joints, it is necessary to use a separate syringe for each joint.

Synovial fluid replacement is a SINGLE-USE MEDICAL DEVICE (REPEATED USE IS PROHIBITED).

Description

The medical device is used in traumatology, orthopedics, sports medicine for the introduction to replace synovial fluid in case of joint damage, to eliminate pain and improve joint mobility. The synovial fluid replacement agent 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 as an auxiliary tool in orthopedic surgery.

Special instructions

Security measures

• The safety and efficacy of injecting this product in parallel with other intra-articular injections have not been studied.
• Efficacy is established only if the minimum recommended course of treatment is followed.
• Synovial fluid replacement should be used with caution in patients with signs of impaired venous or lymphatic outflow in the lower extremities.
• For bilateral treatment, separate syringes should be used for each knee or hip joint.
• Do not use local painkillers if it is known that the patient has an allergy or hypersensitivity to local anesthetics.
• Do not inject into the hip joint under X-ray control and with the use of X-ray contrast agents, if it is known that the patient has an allergy or hypersensitivity to X-ray contrast agents.
• STERILE CONTENTS. The pre-filled syringe is intended for single use. The contents of the syringe should be used immediately after the container is opened. Any unused amount of synovial fluid replacement Product should be disposed of.
• It is necessary to check the expiration date and the integrity of the individual packaging (syringe) before using the medical device. It is forbidden to use after the expiration date, as well as in the case of open or damaged packaging.

Application risks

The manufacturer defines the risks for the patient associated with the occurrence of each type of hazard and the onset of their consequences. The parameters of risk reduction are calculated when applying measures to prevent the occurrence of conditions for the manifestation of dangerous factors or the occurrence of their consequences.

It is established that after the introduction of risk control measures, no new risks arise, and the overall residual risk is recognized as acceptable; the composition and type of packaging of a medical product does not change the risks during production.

Patient Information

• As with all invasive procedures performed on the joints, the patient is advised to avoid any physical exertion, as well as prolonged (lasting for more than 1 hour) activities related to carrying weight loads (this applies, for example, to recreational running and tennis) for 48 hours after intra-articular insertion of the product.
• The safety and efficacy of the Drug for synovial fluid replacement in women during pregnancy and lactation, as well as in children under 18 years of age, has not been established.

Sterility

The product is delivered sterile. Parameters of sterilization: steam method of sterilization in accordance with the requirements of GOST R ISO 17665-1.

Repeated sterilization of the product is prohibited. Repeated use is prohibited.

Biodegradation of a medical device in the patient’s body

The protective film formed after the introduction of a synovial fluid replacement Agent retains its elasticity properties for 6 months.

After 6 months, the synovial fluid replacement agent breaks down under the influence of a group of tissue enzymes called hyaluronidases into decomposition products: oligosaccharides and low-molecular-weight hyaluronates, which are then excreted from the body in a natural metabolic way.

Extraction or replacement of the synovial fluid replacement Agent is not possible, as it is inextricably mixed with the synovial fluid of the joint.

The manufacturer guarantees that the quality of the product meets the requirements of technical specifications, subject to the conditions of use, packaging integrity, transportation and storage conditions in accordance with the manufacturer’s instructions for use. The warranty period for storage in packaging is 3 years from the date of production (packaging). After the warranty period expires, the product must be disposed of.

Storage conditions

The medical device is used indoors at ambient temperatures from 2°C to 25°C.

Transportation must be carried out by all types of transport, in closed vehicles, in accordance with the rules of cargo transportation applicable to this type of transport.

Transport the synovial fluid replacement product in the manufacturer’s packaging at a temperature of 2°C to 25°C and a relative humidity of 30 to 75% without condensation.

Store the synovial fluid replacement product in the packaging of the manufacturer, in a place protected from direct sunlight, heat and freezing, at a temperature of 2°C to 25°C and a relative humidity of 30 to 75% without condensation.

Active ingredient

Sodium Hyaluronate

Dosage form

solution for injection