Ripart means for substitution of the synovial fluid of 10 mg/ml 3 ml syringe 1 pc.

The product is intended for administration to replace if damaged synovial fluid of joints, to eliminate pain and improve joint mobility.

It is used for osteoarthritis and other degenerative, traumatic and post-traumatic joints changes: knee, hip and other major joints, as well as an aid in orthopedic surgery.

Agent for substitution of the synovial fluid RIPART is a sterile, pyrogen-free, colorless and transparent viscous solution of high purity sodium hyaluronate produced by biofermentation method. Sodium hyaluronate – a sodium salt of hyaluronic acid, glycosaminoglycan formed by the groups represented by D – glucuronic acid and N – acetyl – D – glyukozaminodisaharid.

It is widely represented in the extracellular matrix in both animals and humans. Hyaluronic acid belongs to a small group of substances which are the same for all living organisms. Hyaluronic acid is a natural polysaccharide which is included in all body tissues, with particularly high concentrations in the hyaluronic acid is present in the skin and synovial fluid.

 Agent for substitution of the synovial fluid RIPART consists of stabilized produced in a biosynthetic pathway of hyaluronic acid and purified. Hyaluronic acid in the body is a natural component of synovial fluid, which lubricates the joint cartilage and ligaments, as well as a shock absorber.

It is known that synovial fluid in affected joints, has a lower viscosity and elasticity than healthy synovial fluid in the joints. Hyaluronic acid injections into the joint to restore the viscosity and elasticity can reduce pain and restore mobility in the joint. This medical product should only be used by specially trained personnel in the health care environment.

The product is supplied sterile.

sterilization parameters: steam sterilization method in accordance with the GOST P ISO 11134-2000.

The product is non-pyrogenic. Re-sterilization is prohibited. Repeated use is prohibited.

Information for Patients:

After intra-articular administration the means for substitution of the synovial fluid RIPART RIPART Long and may cause pains and passing (or) joint swelling, which produced a product introduction.

As with any invasive procedures performed on joints, the patient is advised to avoid any physical exertion and prolonged (lasting for more than 1:00) activities related to the bearing of weight loads (this applies, for example, training jogging and tennis ) for 48 hours after intra-articular injection.

  The use in the case of special patient groups:
Safety and efficacy of the use of funds for replacement of synovial fluid and RIPART RIPART Long in pregnant women has not been established.

Safety and effectiveness of tools for replacement of synovial fluid and RIPART RIPART Long in women during lactation has not been established.

Safety and efficacy of the use of funds for replacement of synovial fluid and RIPART RIPART Long in children has not been confirmed.

Retention period of therapeutic action and degradation of the medical device in the patient. The protective film is formed after the introduction of the medical device and RIPART RIPART Long retains its elastic properties for 6 months.

After 6 months, medical device and RIPART RIPART Long breaks down under the influence of a group of tissue enzyme called hyaluronidase on decomposition products: oligosaccharides and low molecular weight hyaluronate, which are further removed from the body.

Active substance:
Hyaluronic acid

Manufacturer

Inhalation Ltd., Russia

Composition

Sodium hyaluronate at a concentration of 10 mg / ml, which is dissolved in a physiological sodium – chloride – phosphate buffer solution (pH 6.8 – 7.5).

Indications

It is used for osteoarthritis and other degenerative, traumatic and post-traumatic joints changes: knee, hip and other major joints, as well as an aid in orthopedic surgery.

Contraindications

It prohibited to use in patients suffering from hypersensitivity (allergic) to sodium hyaluronate preparations.

It is forbidden to enter the means for substitution of the synovial fluid and RIPART RIPART Long joint in patients who are observed infectious skin diseases or in the portion at which the injection is supposed to conduct.

Side effects

The agent for substitution of the synovial fluid and RIPART RIPART Long has good portability.

Possible side effects include short-term passes injection-site pain and joint swelling.

Typically, such reactions have consequences for 2-3 days and do not affect the effectiveness of the treatment.

Cases of allergic and anaphylactic reactions rarely mentioned.

Failure to observe the precautions for intraarticular injection, in very rare cases it may be septic arthritis.

How to accept, acceptance rate and dosage

1. Agent for substitution of the synovial fluid and RIPART RIPART Long singly administered intra-articularly (at intervals of one week), a total of 5 injections do. Subcutaneous administration of lidocaine or other local anesthetic may be advised before administration and RIPART RIPART Long product.

2. Introducing the means for substitution of the synovial fluid and RIPART RIPART Long in the affected joint can exclusively competent physician or other medical personnel in hospitals, suitably equipped for performing intra-articular injection.

3. Do not simultaneous application (for skin preparation) disinfectants comprising quaternary ammonium salts, as sodium hyaluronate in their presence may form a precipitate.

4. Do not use the means for substitution of the synovial fluid and RIPART RIPART Long, if the blister pack is opened or has signs of damage. Do not use the drug after its expiration date printed on the package.

5. Be sure to strict compliance with all the strict requirements for the introduction of aseptic products.

6. If necessary (if any), remove the effusion before introduction means for replacing synovial liquid and RIPART RIPART Long.

It is necessary to remove the screw cap and the syringe tip cap of the needle with all the aseptic rules. Introduction RIPART RIPART Long preparation and the joint must be performed at an appropriate size needle (selected taking into account the size of the joint). The needle in the product packaging is not included.

Inject each joint in the full volume of the drug (2 ml into the knee or hip joint, in 1 ml shallow joint). If you have a doctor’s prescription, suggesting the introduction of a few joints, each joint is necessary to use a separate syringe.

7. The pre-filled syringe is intended for single use only and must be used immediately after removal from the packaging. Any remaining amount of funds for replacement of synovial fluid and RIPART RIPART Long must be disposed of, using it is no longer subject.

Active substance

Hyaluronic acid