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.

Active ingredient

Sodium hyaluronate

Composition

One milliliter contains:

• Sodium hyaluronate 15 mg
• Sodium dihydrophosphate 0.1 mg
• Dinatrium hydrophosphate 0.6 mg
• Sodium chloride, 0.9% solution for infusion – up to the volume of 1 ml

How to take, the dosage

The amount of Synovial Fluid Replacement is dependent on the size of the joint. The physician is responsible for determining the applicable volume and must ensure that the joint is not overloaded.

The treatment with RIPART® Forte usually requires a cycle of 1-3 injections (1 week apart).

The choice of dosage is left to the discretion of the treating physician.

The course may be repeated if necessary.

The decision about whether to repeat a course is at the discretion of the physician.

How to use the product

1. The synovial fluid replacement product is injected intra-articularly once. Subcutaneous injection of lidocaine or similar local anesthetic may be recommended prior to the administration of Synovial Fluid Replacement.
2. The Synovial Fluid Substitute must not be used if the blister pack has been opened or shows signs of damage. Do not use the product after the expiration date printed on the package.
3. When preparing for and using the medical product itself, strict adherence to asepsis rules is required.
4. If necessary (if present), remove the joint effusion before administering the Synovial Fluid Substitute.
5. The syringe screw cap and the needle tip cap must be removed in accordance with all aseptic rules. Injection of the synovial fluid substitute into the joint must be done with a needle of the appropriate size (chosen according to the size of the joint). The needle is not included in the product package.

Inject the required volume of Synovial Fluid Replacement Agent into each joint. If there is a doctor’s order to give in more than one joint, a separate syringe should be used for each joint.

The Synovial Fluid Replacement Product is a SINGLE MEDICAL USE (DO NOT REQUIRE USE).

Special Instructions

Cautions

• The safety and effectiveness of injecting this product in conjunction with other intra-articular injections has not been studied.
• Effectiveness has been established only when the minimum recommended course of treatment has been followed.
• Synovial fluid replacement product should be used with caution in patients with evidence of impaired venous or lymphatic outflow in the lower extremities.
• In bilateral treatment, separate syringes should be used for each knee or hip joint.
• Do not use local anesthetic if the patient is known to be allergic or hypersensitive to local anesthetic agents.
• Do not inject into the hip joint under radiological control and using x-ray contrast agents if the patient is known to be allergic or hypersensitive to x-ray contrast agents.
• The SERIES. 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 should be disposed of.
• The expiration date and the integrity of the individual packaging (syringe) should be checked before using the medical product. Do not use after the expiration date or if the package is open or damaged.

Risks of Use

The manufacturer has defined the risks to the patient associated with the occurrence of each type of hazard and the occurrence of their consequences. The parameters of risk reduction are calculated with the application of measures to prevent conditions for the occurrence of hazards or the occurrence of their consequences.

It is established that no new risks arise after the implementation of risk control measures, and the overall residual risk is recognized as acceptable; the risks in manufacturing do not change from the composition and type of packaging of the medical device.

Patient Information

• .As with any invasive joint procedure, the patient is advised to avoid all physical activity and prolonged (more than 1 hour) weight-bearing activities (e.g. jogging and tennis) for 48 hours following intra-articular placement of the product.
• The safety and efficacy of Synovial Replacement Product in women during pregnancy and lactation and in children under 18 years has not been established.

Serility

The product is supplied sterile. Sterilization parameters: steam sterilization method according to GOST R ISO 17665-1.

Re-sterilization of the product is prohibited. Re-use is prohibited.

Biodegradation of the medical device in the patient

The protective film formed after the injection of the Synovial Fluid Substitute retains its elastic properties for 6 months.

After six months, Synovial Fluid Replacement breaks down under the action of a group of tissue enzymes called hyaluronidases into breakdown products: oligosaccharides and low-molecular-weight hyaluronates, which are then eliminated from the body naturally by metabolic processes.

The Synovial Replacement Product cannot be removed or replaced as it is inseparably mixed with the synovial fluid of the joint.

Warranty

The manufacturer guarantees that the product meets the quality requirements of the specifications when the conditions of use, integrity of packaging, shipping and storage conditions in accordance with the manufacturer’s instructions for use are observed.

Warranty period when stored in the package is 3 years from the date of manufacture (packaging).

The product is subject to disposal at the end of the warranty period.

Contraindications

• It is prohibited to use in patients suffering from hypersensitivity (allergy) to products containing sodium hyaluronate.
• It is prohibited to inject the synovial fluid replacement product in the joints of patients who have infectious or skin diseases in the area where the injection is to be made.

Side effects

The synovial fluid replacement product is well tolerated. Possible side effects include transient passing pain at the injection site, fever, bruising, redness and/or swelling. As a rule, such reactions disappear within 2-3 days and do not affect the effectiveness of the treatment in any way. Allergic and anaphylactic reactions are rare. Septic arthritis may occur in very rare cases if the precautions for intraarticular injection are not observed.

Similarities

Ostenil, Fermatron, GOU-ON, Ostenil Plus, Fermatron Plus, Adant, Heimovis, Hyalripayer-10 Chondroreparant, Armaviscon , Optinol, Hyalon prosthesis