Description
Pharmacological action of
Syrup for replacement of synovial fluid RIPART Long is a sterile, pyrogen-free colorless and transparent viscous solution of highly purified sodium hyaluronate obtained by bio-fermentation. The product contains sodium gualuronate at a concentration of 20 mg / ml, Sodium dihydrogen phosphate, Disodium hydrogen phosphate, Sodium chloride, Water for injection.
Sodium hyaluronate is the sodium salt of hyaluronic acid, a glycosaminoglycan formed by groups, representing D-glucuronic acid and M-acetyl-O-glucosaminodisaccharide. It is widely represented in the extracellular matrix in both animals and humans.
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 body tissues, while in a particularly high concentration of sodium, hyaluronate is found in the synovial fluid and skin.
RIPART Long Synovial Fluid Replacement Product consists of a biosynthetic stabilized and purified sodium hyaluronate. Sodium hyaluronate 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 sodium hyaluronate 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.
Contraindications
It is forbidden to use in patients suffering from hypersensitivity (allergy) to products containing sodium hyaluronate.
It is forbidden to administer RIPART Long Synovial Fluid Remedy 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.
Special instructions
– The safety and effectiveness of the injection of this drug in parallel with other intraarticular injections have not been studied.
– The effectiveness of a single cycle of procedures consisting of less than 5 injections has not been established.
– It is imperative to follow all the strict requirements of the aseptic administration technique.
– If there is an articular effusion, remove it before administering Synovial Remedy.
– RIPART Long Synovial Fluid Replacement Agent 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.
– Local painkillers should not be used if the patient is known to have an allergy or hypersensitivity to local anesthetics.
– Do not inject into the hip joint under radiological control and using radiopaque substances, if the patient is known to be allergic or hypersensitive to x-ray contrast agents.
STERILE CONTENT. A 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 RIPART Long Synovial Fluid Replacement Agent should be disposed of.
It is forbidden to use the RIPART Long Synovial Fluid Replacement Agent, if the blister pack is opened or damaged.
Composition
Active ingredient:
sodium gualuronate 20 mg.
Dosage and administration
RIPART Long synovial fluid replacement agent is administered intraarticularly once (at intervals of one week), for a total of 5 injections. Subcutaneous administration of lidocaine or a similar local anesthetic may be recommended prior to administration of the RIPART Long product.
The RIPART Long Synovial Fluid Replacement Agent may only be injected into the affected joint by a competent doctor or other medical staff in medical facilities properly equipped for intra-articular injections.
The simultaneous use (for skin preparation) of disinfectants containing quaternary ammonium salts is prohibited, since sodium hyaluronate in their presence can form a precipitate.
It is forbidden to use the RIPART Long Synovial Fluid Replacement Agent if the blister pack is opened or has signs of damage. It is forbidden to use the drug after the expiration date indicated on the package.
Be sure to strictly comply with all the strict requirements for the introduction of aseptic drugs.
If necessary (if any), remove articular effusion before administration of RIPART Long Synovial Fluid Replacement Agent.
It is necessary to remove the screw cap of the syringe and the cap of the needle tip in compliance with all aseptic rules. Introduction Means for replacing the RIPART Long synovial fluid in the joint must be carried out using a needle of the appropriate size (selected according to the size of the joint). The needle is not included in the product packaging.
Introduce into each joint the full volume of RIPART Long Synovial Fluid Replacement Agent (2 ml into the knee or hip joint, 1 ml into the small joint). If there is a medical prescription that involves the introduction of several joints, for each joint it is necessary to use its own separate syringe.
The pre-filled syringe is for single use only and must be used immediately after removal from the package.
Any remaining quantity of RIPART Long Synovial Fluid Replacement Agent must be disposed of, it is no longer subject to use.
RIPART Long Synovial Fluid Replacement Agent is a DISPOSABLE MEDICAL PRODUCT (RE-USE FORBIDDEN).
Side effects
Syrup for replacement of synovial fluid RIPART Long is well tolerated.
Possible side effects include short-term passing pain at the injection site and / or 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 rare.
If precautions are not taken during intra-articular administration, septic arthritis may occur in very rare cases.
Storage conditions
At a temperature not exceeding + 25 ° С and not lower than + 2 ° С.
Active ingredient
Sodium hyaluronate
Terms of delivery from
pharmacies Prescription
Dosage form
solution for injection
