Expiration date: 01/2025
Composition
Implant for intra-articular injections 3 ml
active substance:
sodium hyaluronate 60 mg (2%)
phosphate buffer salt solution:
Na2HPO4·12H2O — 0,134%
NaH2PO4·2H2O - 0.004%
sodium chloride - 0.85%
water for injection - how much will it take up to 100%
Characteristic
The implant is a colorless, transparent, viscous, sterile and apyrogenic hydrogel. The functional ingredient of the product is stabilized hyaluronic acid, obtained by fermentation of Streptococcus zooepidemicus bacteria.
Diglycidyl ether of 1,4-butanediol is used as a cross-linking agent to produce cross-linked hyaluronic acid.
Technical specifications:
pH 6,8–7,8;
Viscoelasticity (G'/G") 100-200/20-40 Pa;
osmolality 0.9-1.3 to 0.9% saline solution;
osmolality 270~390 mOsm/kg.
Pharmacological action
Pharmacological action - replenishing the deficiency of synovial fluid.
Effect on the body
The implant acts as a barrier protecting the joint. The injection of hyaluronic acid protects the tissues of the joint cavity, softening the external mechanical pressure.
Properties of components
Hyaluronic acid is a natural polysaccharide and an important structural element of the skin, subcutaneous and connective tissues, in particular synovial fluid. Hyaluronic acid has a high biological compatibility and is the same in all living organisms. 1 ml of the implant contains 20 mg of sodium hyaluronate in a phosphate buffer saline solution.
The hyaluronic acid molecule has a spiral long-chain structure that allows it to retain or absorb water molecules. These properties provide a lubricating and cushioning effect inside the joint. Osteoarthritis, known as degenerative arthritis, often leads to the destruction of collagen and loss of proteoglycans.
Recommended
Treatment of joint pain in osteoarthritis in patients who do not have an adequate response to conservative non-drug therapy and mild analgesics.
Contraindications
Patients with hypersensitivity to products based on hyaluronate.
Intra-articular injections are contraindicated in the case of past or current infections or skin diseases in the immediate vicinity of the injection site.
Use during pregnancy and lactation
If the expected positive therapeutic effect outweighs the negative impact of side effects, it is recommended to use an implant. During the treatment period, nursing women need to stop breastfeeding.
Side effects
Pain, swelling and stiffness in the knee where the injection was made.
Method of administration and dosage
Intra-articular.
The product is intended for use by qualified specialists and medical professionals in licensed institutions or hospitals.
The implant is intended for one-time use only.
The implant is inserted in the volume contained in one syringe, designed for one adult patient, into a joint affected by osteoarthritis. The implant is injected directly into the joint cavity.
The product is prescribed by the recommended course — 1 syringe for treatment for adults. The product is used for injection into the joint cavity. The dosage is 3 ml per course of treatment, so adults should inject the entire contents of the syringe. The therapeutic effect of using the product persists for at least 6 months.
Before the injection, it is necessary to remove the covering membrane and remove the filled syringe with the implant from the blister, carefully remove the lid up together with the protective cap, attach the necessary size (21–23G) sterile needle and fix it by turning it slightly; before injection, release air bubbles from the syringe if there are any.
Children
There are no exact data on the safety of the use of the implant in children, therefore, during treatment, the doctor is obliged to closely monitor the condition of children's patients.
Old age
Due to the weakened state of the body in the elderly, the attending physician needs to closely monitor their condition when using the implant.
Special instructions
The medical device is intended for use as an intra-articular implant. It is forbidden to re-sterilize the implant or mix it with other drugs. Do not use the implant if its packaging is broken.
The attending physician should pay special attention to patients with a history of allergic reactions to medications, as well as liver diseases.
It is necessary to observe general precautions for intra-articular injections, as well as measures to prevent infection of the joint. The implant should be inserted only into the joint cavity, using visual inspection tools if necessary. Avoid getting the medical device into the surrounding tissues or blood vessels! In case of inflammatory phenomena in the joint, exercise increased caution.
It is not recommended for use in rheumatoid arthritis in the active stage.
Repeated use of the same syringe with an implant can lead to the development of infection and a serious inflammatory reaction.
Extraction of the implant. In case of pronounced manifestations, removal of the implant from the joint cavity may be recommended, including with the use of lavage, according to current clinical recommendations. Repeated injections of synovial fluid implants into the joint are prohibited until the symptoms of acute inflammation are relieved!
The implant does not have an electromagnetic effect, does not emit radioactive radiation and is not a possible source of radiation pollution, does not have a heat-insulating effect, does not have a mechanized functional, does not contain drugs, human blood derivatives, animal tissues.
Do not twist or rotate the plunger of the syringe, because this can lead to leakage of the implant, deformation of the piston and an increase in the extrusion force. The syringe, needle and any unused materials must be disposed of immediately after the injection. Read the instructions carefully before using.
Release form
An implant for intra-articular injections. Hydrogel 60 mg/3 ml in a stoppered, sterile glass syringe with a piston reverse stroke limiter and a piston. 1 filled syringe sealed in a blister, 3 implantation stickers together with instructions for use are placed in a cardboard box.
Manufacturer
"SciVision Biotech Inc.", Taiwan, Republic of China./SciVision Biotech Inc. 9, South 6th Rd., K.E.P.Z., Kaohsiung 806, Taiwan, R.O.C.
e-mail: [email protected]
Tel.: +886-7-823-2258.
Authorized representative of the manufacturer: Limited Liability Company "MKNT Import" (LLC "MKNT Import"), Russia, 119071, Moscow, Ordzhonikidze str., 12, p. 2.
Tel.: (495) 786-39-63.
e-mail: [email protected]
Storage conditions
In a place protected from sunlight, at a temperature of 2-30 ° C, do not freeze in the original packaging.
Keep out of reach of children.
Expiration date
3 years
Do not use after the expiration date indicated on the package.
