Ripart Forte 15mg/ml syringe 3 ml

Osteoarthritis and other degenerative-dystrophic, traumatic and post-traumatic changes of joints: knees, hips and other joints.

As an aid in orthopedic surgery.

For use in patients with increased physical activity and who regularly load the damaged joint.

Indications

Osteoarthritis and other degenerative-dystrophic, traumatic and post-traumatic changes in joints: knee, hip and other joints.

As an aid in orthopedic surgery.

For use in patients who have increased physical activity and regularly load the damaged joint.

Special instructions

Precautions

The safety and effectiveness of injecting this product in parallel with other intra-articular injections have not been studied.
Efficacy has only been established if the minimum recommended course of treatment is followed.
The synovial fluid replacement agent should be used with caution in patients with signs of impaired venous or lymphatic drainage in the lower extremities.
For bilateral treatment, separate syringes should be used for each knee or hip joint.
Local anesthetics should not be used if the patient is known to be allergic or hypersensitive to local anesthetics.
X-ray-guided hip injections should not be performed using radiocontrast agents if the patient is known to be allergic or hypersensitive to radiocontrast agents.
STERILE CONTENTS. The pre-filled syringe is intended for single use. The contents of the syringe must be used immediately after the container is opened. Any unused amount of Synovial Fluid Replacement Agent should be discarded.
It is necessary to check the expiration date and the integrity of the individual packaging (syringe) before using the medical device. Do not use after the expiration date, or if the packaging is open or damaged.

Risks of use

The manufacturer has determined the risks for the patient associated with the occurrence of each type of hazardous factors and the occurrence of their consequences. The parameters for reducing risks when applying measures to prevent the occurrence of conditions for the manifestation of hazardous factors or the occurrence of their consequences are calculated.

It has been established that after the implementation of risk control measures, no new risks arise, and the overall residual risk is considered acceptable; The production risks do not change depending on the composition and type of packaging of a medical product.

Patient Information

As with any invasive joint procedure, the patient is advised to avoid any strenuous exercise or prolonged (longer than 1 hour) weight-bearing activities (such as jogging and tennis) for 48 hours after intra-articular insertion.
The safety and effectiveness of the use of synovial fluid replacement agents in women during pregnancy and lactation, as well as in children under 18 years of age, have not been established.

Sterility

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

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

Biodegradation of a medical device in the patient’s body

The protective film formed after the introduction of the synovial fluid replacement agent retains its elastic 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 subsequently excreted from the body through natural metabolic pathways.

Removal or replacement Synovial fluid replacement agents are not possible because it is inseparably mixed with the synovial fluid of the joint.

Guarantees

The manufacturer guarantees that the quality of the product meets the requirements of technical specifications, subject to the conditions of use, integrity of packaging, transportation and storage conditions in accordance with the manufacturer’s instructions for use.

The warranty period when stored in packaging is 3 years from the date of production (packaging).

After the warranty period expires, the product must be disposed of.

Composition

One milliliter contains:
Sodium hyaluronate 15 mg
Sodium dihydrogen phosphate 0.1 mg
Disodium hydrogen phosphate 0.6 mg
Sodium chloride, solution for infusion 0.9% – up to a volume of 1 ml

Contraindications

Do not use in patients suffering from hypersensitivity (allergy) to products containing sodium hyaluronate.
It is prohibited to inject the Synovial Fluid Replacement Agent into the joint of patients who have infectious or skin diseases in the area where the injection is intended.

Side Effects

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

Specifications

The synovial fluid replacement product is a sterile, colorless and transparent viscous solution of highly purified sodium hyaluronate, obtained by biofermentation. The product contains sodium hyaluronate at a concentration of 15 mg/ml sodium dihydrogen phosphate, disodium hydrogen phosphate, sodium chloride 0.9% solution for infusion.
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 the synovial fluid replacement agent must 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 natural polysaccharide that is part of all tissues of the body, and sodium hyaluronate is found in especially high concentrations in synovial fluid and skin. The synovial fluid replacement agent consists of biosynthetically produced and purified sodium hyaluronate. Sodium hyaluronate in the body is a natural constituent of synovial fluid, which in joints serves as a lubricant for cartilage and ligaments, and is also an shock absorber. It is known that synovial fluid in affected joints has lower viscosity and elasticity than synovial fluid in healthy joints. Injecting sodium hyaluronate into a joint to restore viscosity and elasticity can reduce pain and restore joint mobility.
The composition of the synovial fluid replacement agent ensures the restoration of viscoelastic properties and the transition of the viscous properties of the solution into 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.

Prescribing

The medical device is used in traumatology, orthopedics, and sports medicine for administration to replace synovial fluid in case of joint damage, to eliminate pain and improve joint mobility. The agent for replacing synovial fluid 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 aid in orthopedic surgery.

Storage conditions

The medical device is used indoors at an ambient temperature of 2°C to 25°C.

Transportation must be carried out by all types of transport, in closed vehicles, in accordance with the rules for the carriage of goods in force for this type of transport.

The synovial fluid replacement agent must be transported in the manufacturer’s packaging at a temperature from 2°C to 25°C and relative humidity from 30 to 75% without moisture condensation.

The synovial fluid replacement product must be stored in the manufacturer’s packaging, protected from direct sunlight, heat and freezing, at a temperature from 2°C to 25°C and relative humidity from 30 to 75% without moisture condensation.

Manufacturer

Ingal LLC, Russia