HYAJOINT Plus Synovial Fluid Supplement is a product supplied in a glass syringe with hyaluronic acid. The product is a clear, lucid, viscous, sterile and nonpyrogenic solution with a pH of 6.8 - 7.8. The hyaluronic acid stabilized is extracted from microorganism. Hyaluronic acid is a natural polysaccharide in synovial fluid which is identical in all living organisms and highly biocompatible.
Each one mL of the product contains 20 mg of sodium hyaluronate dissolved in physiology saline.
Active ingredient: Sodium hyaluronate 60 mg.
Excipients/Inactive Ingredients: Disodium phosphate dodecahydrate, Sodium dihydrogen phosphate dihydrate, Sodium chloride, Sterile water for injection q.s. to 3.0 mL.
Therapeutic efficacy: The product can counterbalance the mechanical stress transmitted from outside. It is a barrier protecting the joint. The product can protect synovial tissues and promote healing of articular cartilage. Anticipated duration of efficacy is at least 6 months after the product treatment.
The product is indicated for treatment of pain in osteoarthritis (OA) of the knee joint.
The product is used 1 syringe per treatment for adult into the osteoarthritis (OA) joint.
Bring the product to room temperature before use.
The product is used for injecting to articular cavity of joint with a 21-23G needle.
Remove effusion before injecting the product.
Inject slowly to ensure product usability.
The patient should avoid any strenuous activities or weight-bearing activities within 48 hours following intra-articular injection.
Do not administer to patients with known hypersensitivity to hyaluronate preparations.
Intra-articular injections are contraindicated in cases of past and present infections or skin diseases in the area of the injection site.
The product is intended for use as intra-articular implant only.
The product is for single use only. If re-using, it may cause infection, even seriously inflammatory response.
Do not re-sterilize the product.
Do not mix with quaternary ammonium salts to prevent precipitation.
Do not mix any pharmaceutical products. The study of interactions have not been established.
Do not inject the product into blood vessels to prevent vascular occlusion, embolization, ischemia or infarction.
Do not inject the product into surrounding tissues to ensure product efficacy. If necessary, medical imaging approaches may improve injection accuracy.
Do not overtighten the needle to prevent product leakage, and avoid increasing extrusion force.
Do not overtighten the needle to prevent luer-lock loosed and product leakage.
Use in Pregnancy & Lactation: See Use in Pregnancy & Lactation.
Use in Children: The safety of use for children has not been demonstrated.
The safety of use for mothers-to-be and lactation has not been demonstrated.
The major adverse events are pain and swelling to the treated knee. Few adverse events are stiffness, effusion, paraesthesia, limb pain/weakness and soreness.
Directions for use: 1. Manually clip the finger adaptor to the flange of the syringe barrel.
2. Hold luer-lock site and unscrew the tip cap of syringe carefully. Do not hold syringe barrel during assembling.
3. Keep holding luer-lock site firmly and screw the needle to the latch of syringe until fastened assembled.
Note: The product is only intended to be administered by authorized personnel in accordance with local legislation. The syringe, the needle and any unused material must be discarded directly according to national regulations after the treatment session.
Store at 2-30°C. Protect from sunlight and freezing.
Shelf life: 3 years.
M09AX01 - hyaluronic acid ; Belongs to the class of other drugs for disorders of the musculo-skeletal system.
Hyajoint Plus inj 60 mg/3 mL
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