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Hyalur cs synovial fluid prosthesis 0.06/3 ml + 0.09/3 ml syringe №1
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Prosthesis synovial fluid CS hyalur solution of sodium hyaluronate
Description
CS hyalurum is a synovial fluid prosthesis, a sterile, transparent viscoelastic solution, which consists of sodium hyaluronate 60 mg / 3 ml and chondroitin sodium sulfate 90 mg / 3 ml.
Hyaluronic acid is the main component of the synovial fluid, determining its viscoelastic properties. It forms on the entire inner surface of the joint a covering layer that protects the cartilage and the synovial membrane from mechanical damage, as well as from free radicals and inflammatory factors.
Chondroitin sulfate is one of the natural glycosaminoglycans (GAG), consisting of alternative sugar D-glucuronic acid and N-acetyl-D-galactosamine. Chondroitin sulfate is obtained in the form of sodium salt from cattle trachea and is used to prepare active pharmaceutical substances.
Chondroitin sulfate is a stimulator of tissue regeneration, contributes to the retention of water and the restoration of shock-absorbing functions in cartilage tissues. Promotes the synthesis and protection of collagen, which is the structural basis of all connective tissues,and also increases the production of hyaluronic acid in synovial cells, which has a beneficial effect on maintaining the viscosity of synovial fluid.
The use of chondroitin sulfate together with sodium hyaluronate helps to slow down the degradation and stimulates the regeneration of cartilage.
Composition
- 1 prefilled syringe with Hyalur CS
- Sodium Hyaluronate 60.00 mg
- Chondroitin sodium sulfate 90.00 mg
- Sodium Chloride 10.50 mg
- Excipients
- Water for injection up to 3.00 ml
Main technical specifications
Hyalur CS is a clear, viscous solution from colorless to brown in disposable hydrolytic class I glass syringes equipped with a Luer Lock-type needle fixing system, complete with a three-edged laser-sharpened needle.
Scope of application: surgery, traumatology, orthopedics, rheumatology.
Indications
Hyalur CS is used:
- for symptomatic treatment of mild, moderate or severe osteoarthritis;
- with pain and limited mobility caused by degenerative-dystrophic or post-traumatic changes of the knee, hip and other synovial joints;
- to relieve pain after arthroscopy (use is possible no earlier than 1 week after the intervention).
Contraindications
- established hypersensitivity to the components of this medical device;
- the presence of active inflammatory or infectious processes in the joint;
- signs of active skin disease or skin infection in the area of the intended injection;
- use in patients with an established diagnosis of an autoimmune disease or undergoing immunotherapy;
- use during pregnancy or lactation;
- age up to 18 years.
Application
Hyalur CS is intended for intraarticular injection.
The solution should not be injected outside the joint cavity, as well as in patients with infections or skin diseases in the area of the injection.
Intra-articular injection should be administered by specialists who have been trained in the technique of intra-articular injection and should be made under aseptic conditions in medical institutions.
Perhaps the use of local anesthetics before the intra-articular injection, for example, subcutaneous injection of Lidocaine.
It is necessary to properly disinfect the injection site (use a solution of alcohol 70% or other disinfectants). Disinfectants containing quaternary ammonium salts (eg, benzalkonium chloride) should not be used, since precipitation is possible.
Before the introduction of Hyaluroma CS, fluid should be removed from the joint cavity. It is recommended to conduct arthrocentesis before the solution is injected
After removing the protective cap from the syringe tip, attach a sterile needle to the syringe. Usually, a needle with a size of 0.8x40 mm (21G) is used for the knee joint, for other joints we recommend using a needle of the required size (from 17G to 22G) depending on the joint.
Hyalur CS is injected into the joint in volume, depending on the size of the joint. The joint cavity should not be overloaded.
Each pre-filled syringe is intended for single use. The contents of the syringe should be used immediately after opening. Unused completely solution is not subject to storage and should not be re-sterilized.
After the injection of Hyaluroma CS, the patient is advised to adhere to a gentle regimen and avoid excessive or prolonged stress on the joints (for example, running or playing tennis) for 48 hours.
Introduction Precautions
Before use, check the expiration date and the integrity of the package.
Do not use after the expiration date printed on the package. The use of open and / or damaged sterile packaging is not allowed.
Needles and syringes used for injection should not be reused. Re-sterilization is not allowed.
Properties and Efficiency
Hyalur CS is designed to replenish the volume and restore the viscosity of synovial fluid in the joints. Hyalur CS is dissolved in synovial fluid, providing a beneficial effect. It undergoes local transformations in the joint cavity, normalizes the properties of the synovial fluid, returning its lubricating and shock-absorbing functions. The highest concentrations of hyaluronic acid in studies were found in synovial fluid and the articular capsule, lower concentrations in the synovial membrane, ligaments and adjacent muscles, the excretion is mainly carried out by the kidneys.
The introduction of a single injection is recommended, the effect lasts from 6 to 12 months. This osteoarthritis therapy is generally accepted, safe and effective.
When administered once with CS hyalur, it restores the lubricating and depreciation properties of synovial fluid, has a pronounced and long-term analgesic effect and significantly reduces the limitation of joint mobility.
Sodium hyaluronate is obtained by bacterial fermentation.
There are no data on incompatibility of use simultaneously with drugs.
Hyalur CS is a medical device.
Side effects
You may experience mild pain and swelling at the injection site. The above symptoms are transient and usually disappear after 72 hours.
Packaging
Hyalur CS is a sterile solution for intra-articular injection in pre-filled disposable syringes of hydrolytic glass I class, with a volume of 3 ml, containing sodium hyaluronate 60 mg / 3 ml and chondroitin sodium sulfate 90 mg / 3 ml.
Packaging - 1 pre-filled syringe, 1 injection sterile needle (EO) 0.8 x 40 mm (21G) in a cell plastic bag together with instructions for use in a cardboard box.
Storage conditions
Store at a temperature not exceeding 25 ° C, in its original packaging, in a dry place.
Do not freeze. Keep out of the reach of children.
Shelf life
2 years. Do not use after the expiration date.