pharmachologic effect
Solution for intra-articular administration Gialurom is a sterile, pyrogen-free, viscoelastic solution of sodium hyaluronate for intra-articular administration, intended to restore the properties of synovial fluid.
Sodium hyaluronate is a polysaccharide identical to human, consisting of repeating disaccharide units of N-acetylglycosamine and sodium glucuronate, with a molecular weight exceeding 2,400,000 Da. Obtained as a result of bacterial fermentation.
Sodium hyaluronate (hyaluronic acid) is the main component of synovial fluid, determining its viscoelastic properties. It forms a covering layer on the entire inner surface of the joint that protects the cartilage and synovial membrane from mechanical damage, as well as from free radicals and inflammatory factors. Hyaluronic acid normalizes the viscoelastic, shock-absorbing and lubricating properties of synovial fluid, stimulates the natural formation of hyaluronic acid and the synthesis of components of the extracellular matrix of cartilage (proteoglycans).
Thus, sodium hyaluronate has analgesic, anti-inflammatory, antioxidant and chondroprotective effects. These effects last for about 6 months after one course of treatment.
Buy Hyalurom CS synovial fluid prosthesis syringe 3ml No. 1 in pharmacies
Composition 1 pre-filled syringe with Hyalur CS contains:
Sodium hyaluronate - 60.00 mg Sodium chondroitin sulfate - 90.00 mg Sodium chloride - 10.50 mg Sodium dihydrogen phosphate monohydrate - 1.35 mg Disodium phosphate dodecahydrate - 15.15 mg Sodium hydroxide and/or hydrochloric acid (to adjust pH) - up to pH = 7.4 ± 0.2 Water for injection - up to 3.00 ml
Description
Hyalurome CS is a synovial fluid prosthesis, a sterile, transparent viscoelastic solution, which contains sodium hyaluronate 60 mg/3 ml and sodium chondroitin sulfate 90 mg/3 ml (registered in the Russian Federation on September 10, 2008, No. RU P N014581/01).
Hyalurom CS is a sterile solution for intra-articular administration - a transparent, viscous solution from colorless to brown.
Hyaluronic acid is the main component of synovial fluid, determining its viscoelastic properties. It forms a covering layer on the entire inner surface of the joint that protects the cartilage and synovial membrane from mechanical damage, as well as from free radicals and inflammatory factors.
Chondroitin sulfate is one of the naturally occurring glycosaminoglycans (GAGs), consisting of the alternative sugar D-glucuronic acid and N-acetyl-D-galactosamine. Chondroitin sulfate is obtained in the form of sodium salt from the trachea of cattle and is used for the preparation of active pharmaceutical ingredients.
Chondroitin sulfate is a stimulator of tissue regeneration, promotes water retention and 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 slow down degradation and stimulate cartilage regeneration.
Main technical characteristics
Hyalurom CS is a transparent viscous solution from colorless to brown in disposable glass syringes of hydrolytic class I, equipped with a Luer Lock needle fixation system, complete with a triangular laser sharpened needle, sharpening angle alpha (11+/-2)°. There is no graduation of the syringe; it is not required, since the contents of one syringe are used once and are intended only for one patient.
Injection needle (grade DIN1.4306, DIN1.4301) made of austenitic high-quality medical stainless steel with low carbon content, sterilized with ethylene oxide (EO).
Hyalurome CS has a dynamic viscosity in the range of 80-140 Pa•s, osmolality is 275-365 mOsmol/kg, solution density is 1.013-1.043 g/cm3.
Field of application: surgery, traumatology, orthopedics, rheumatology.
Properties and efficiency
Hyalurome CS is designed to replenish the volume and restore the viscosity of synovial fluid in the joints. Hyalurome CS dissolves in the synovial fluid, providing a beneficial effect. It undergoes local transformations in the joint cavity, normalizes the properties of synovial fluid, returning its lubricating and shock-absorbing functions. The highest concentrations of hyaluronic acid in studies were found in the synovial fluid and joint capsule, lower concentrations in the synovial membrane, ligaments and adjacent muscles, excretion is mainly carried out by the kidneys.
A single injection is recommended and the effect lasts for at least 6 months. This therapy for osteoarthritis is generally accepted, safe and effective.
Hyalurome CS, when administered once, restores the lubricating and shock-absorbing 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 the incompatibility of use simultaneously with medications.
Hyalurome CS is a medical device.
Special conditions
Precautions for administration
Before use, check the expiration date and the integrity of the packaging.
Do not use after the expiration date stated on the packaging. Use of open and/or damaged sterile packaging is not permitted.
Needles and syringes used for injection should not be reused. Repeated sterilization is not permitted.
Information about recycling and destruction
After use, the syringe and needle should be disposed of in accordance with the requirements of current legislation as epidemiologically hazardous medical waste.
After the expiration date, it can be disposed of with solid household waste in accordance with the requirements of current legislation.
Indications
Hyalur CS is used:
- for the symptomatic treatment of mild, moderate or severe osteoarthritis; - for pain and limitation of mobility caused by degenerative-dystrophic or post-traumatic changes in 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; - presence of 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.
Side effects
Moderate pain and swelling in the injection area may occur. The above symptoms are transient and usually disappear after 72 hours.
Special storage conditions
Do not freeze.
Directions for use and doses
Hyalurome is intended for intra-articular administration.
Hyalurum is injected into the damaged joint in the required volume of up to 2 ml, depending on the size of the joint. The course of therapy consists of 3 injections into one joint with an interval between injections of 7-10 days. Simultaneous treatment of several joints is allowed. If necessary, a repeat course of injections is possible.
Intra-articular injection must be performed by a medical specialist under aseptic conditions.
Each pre-filled syringe is intended for single use. The contents of the syringe must be used immediately after opening. An unused drug cannot be stored and should not be re-sterilized.
It is possible to use local anesthetics during intra-articular injection.
Hyalurom Chondro 60 mg/3 ml and 90 mg/3 ml No. 1 solution for intra-articular administration in a syringe
Instructions for the medical use of a medical device for the consumer Name of the medical device Hyalurom Chondro, solution for intra-articular administration 60 mg/3 ml and 90 mg/3 ml, pre-filled syringe 3 ml, No. 1 Composition and description of the product Pre-filled syringe with solution for intra-articular administration 3 ml, No. 1. 3 ml of solution contains sodium hyaluronate 60 mg, sodium chondroitin sulfate 90 mg, sodium chloride 10.50 mg, sodium dihydrogen phosphate monohydrate 1.35 mg, sodium hydrogen phosphate dodecahydrate 15.15 mg, 1 M sodium hydroxide solution or 1 M hydrochloric acid to pH = 7.4 ± 0.2 and water for injections up to 3 ml. Hyaluron Chondro is a transparent, colorless to brown viscous solution. Hyalurom Chondro is available in the form of a pre-filled syringe made of transparent glass of the first hydrolytic class, siliconized, equipped with an elastomer cap and a finger rest, which contains at least 3 ml of sterile solution. A label is attached to each prefilled syringe. 1 pre-filled syringe is placed in a cellular polymer package coated with marked aluminum foil or unmarked transparent polyethylene film. 1 cell polymer package with a disposable sterile needle 21 G x 1 1/2” along with instructions for medical use in the state and Russian languages in a folding cardboard box. Scope of application For the treatment of diseases of the musculoskeletal system: Hyalurome Chondro acts as a temporary replacement and supplement for synovial fluid. Hyalurome Chondro is intended for the symptomatic treatment of osteoarthritis, from mild to severe. Hyaluron Chondro treats pain and decreased mobility caused by degenerative or traumatic pathologies of the knee and other synovial joints (hip, ankle, shoulder, elbow, wrist, fingers, temporomandibular joint, facet joints). Hyalurom Chondro relieves joint pain, improves joint mobility and protects cartilage. Hyaluron Chondro is also indicated for pain relief after arthroscopy. Hyalurome Chondro is intended to restore the viscosity of synovial fluid. This therapy is safe, effective and well-established in the treatment of osteoarthritis and consists of injecting a hyaluronic acid-based solution into the affected synovial joint. Hyaluronic acid (HA) is a major component of synovial fluid and cartilage and, due to its viscoelastic and rheological properties, is responsible for lubrication and shock absorption in joints. This reduces friction between joint surfaces and protects soft tissue from injury by acting as a shock absorber. Hyaluronic acid also has analgesic, anti-inflammatory, antioxidant, chondroprotective effects and stimulates the synthesis of proteoglycans. The quantity and quality of HA in synovial fluid is reduced in patients with osteoarthritis, since its synthesis by synovial cells and cartilage cells is impaired. Thus, the protection of the joint surfaces is greatly altered and the cartilage becomes vulnerable and subject to structural damage due to frictional and compressive forces. Hyaluron Chondro, administered as a single injection, will restore good lubrication and shock absorption in the joints significantly and for a long time, relieve pain and stiffness of the joints. Method of administration The drug is administered by intra-articular injection. Aseptic administration technique must be strictly observed. The injection site must be properly disinfected (70% alcohol or other disinfectants). Disinfectants containing quaternary ammonium salts should not be used as hyaluronic acid may precipitate under these conditions. Before administration of Hyalur Chondro, any accumulation of fluid in the joints must be removed by suction with a syringe. The finished syringe is removed from the sterile cellular polymer packaging, the cap is removed from the tip of the syringe, after which a sterile needle is put on, which is fixed with a slight turn. Before administration, the air must be removed from the syringe. The amount of Hyaluron Chondro administered depends on the size of the joint. The intra-articular space should not be overloaded. Each prefilled syringe is intended for single use. The contents of the pre-filled syringe are sterile and should be used immediately after opening the package. Throw away unused Hyalur Chondro. The drug should not be re-sterilized. Hyaluron Chondro is administered only by doctors trained in intra-articular injection techniques. Subcutaneous administration of lidocaine or a similar anesthetic may be recommended before the administration of Hyaluroma Chondro. Contents No. Components Manufacturing organization (manufacturer) Country 1 Pre-filled syringe with 3 ml of solution for intra-articular administration, No. 1. 3 ml of solution contains sodium hyaluronate 60 mg, sodium chondroitin sulfate 90 mg, sodium chloride 10.50 mg, sodium dihydrogen phosphate monohydrate 1.35 mg, sodium hydrogen phosphate dodecahydrate 15.15 mg, 1 M sodium hydroxide solution or 1 M hydrochloric acid to pH = 7.4 ± 0.2 and water for injection up to 3 ml. A syringe with a capacity of 3 ml consists of: A syringe body made of clear glass Piston Rod Finger rest BD Medical Pharmaceutical Systems France 2 Injection needle 21 G x 1 1/2'' CHIRANA T. Injecta, as Slovakia Storage conditions At a temperature not exceeding 25 0C, in original packaging. Do not freeze. Keep out of the reach of children! Shelf life: 2 years Do not use after expiration date. The expiration date and the integrity of the packaging must be checked before use. Do not use after the expiration date stated on the package or if the package is damaged. Used needles and syringes should be destroyed after each injection and should not be used for another injection. Manufacturing organization Rompharm Company S.R.L. Name of the regulatory document Specification for a medical device Hyalur Chondro, solution for intra-articular administration 60 mg/3 ml and 90 mg/3 ml, pre-filled syringe 3 ml, No. 1 Side effect Swelling and passing pain may occur after injection. These reactions usually disappear within 72 hours. Contraindications for use · hypersensitivity (including a history of hypersensitivity) to the components of Hyaluron Chondro · patients with infections or skin diseases at the injection site · children and adolescents · pregnant and lactating women · known systemic bleeding disorders Precautions (safety) The drug should not be administered extra-articularly. Injections with Hyalur Chondro should be performed exclusively by licensed and certified doctors of the appropriate profile. Hyaluron Chondro should not be used simultaneously or in mixture with other drugs intended for intra-articular use. The drug is administered only if the solution is clear. First aid measures for misuse or side effects. Similar to other invasive joint procedures, the patient is advised to adhere to a gentle regimen and avoid excessive stress on the joint for 48 hours after intra-articular injection with Hyalur Chondro. Patients with painful consequences after intra-articular injection of Hyalur Chondro should immediately consult a doctor. If pain increases during insertion, the procedure should be stopped.
special instructions
After the Hyaluroma injection, the patient is advised to adhere to a gentle regimen and avoid excessive stress on the joint for several days.
Clinical data on use in pediatrics are insufficient, so the drug should not be prescribed to children.
Clinical data on use during pregnancy and lactation are insufficient, so the drug should be used only for strict indications.
There was no effect on the ability to drive vehicles or perform other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
Contraindications
- established hypersensitivity to the components of this medical device;
- the presence of active inflammatory or infectious processes in the joint;
- presence of signs of active skin disease or skin infection in the area of the intended injection;
- use in patients diagnosed with an autoimmune disease or undergoing immunotherapy;
- use during pregnancy or lactation;
- age up to 18 years.