Sodium hyaluronate gel cross-linked by divinyl sulfone, sodium hyaluronate fluid (4:1).
The product is a sterile, clear colorless viscoelastic gel supplied in a syringe.
The gel contains mixture of sodium hyaluronate hydrogel cross-linked by divinyl sulfone and sodium hyaluronate fluid.
Product Name: Sterile absorbable viscoelastic gel (Sodium hyaluronate gel) for osteoarthritis.
Model Name: YYD-302.
Composition: Each 1 syringe (2 mL) contains: YYD-302: 4:1 w/w mixed hydrogel of sodium hyaluronate gel crosslinked by divinyl sulfone and sodium hyaluronate fluid 2.04 g (as Sodium hyaluronate 40 mg).
Excipients/Inactive Ingredients: Sodium hyaluronate, Divinyl sulfone, Potassium dihydrogen phosphate, Disodium monohydrogen phosphate dodecahydrate, Potassium chloride, Sodium chloride, Water for injection.
Hyaluronic acid is a naturally occurring polysaccharide that exists in many connective tissues such as joint fluid and serves to provide viscoelasticity of joint synovial fluid.
Trauma and degenerative joint diseases reduce hyaluronic acid in the joints and cannot absorb or disperse impacts, resulting in joint damage, which is a source of pain. Intraarticular administration of sodium hyaluronate can replace (substitute) synovial fluid as viscoelastic supplement.
Clinical Benefit: In the treatment of knee osteoarthritis, hyaluronic acid preparations have shown results in various clinical studies indicating improvements in pain and physical function compared to baseline values.
Resyno One Inj. has shown comparable pain relief effects up to 12 weeks in clinical trials compared to similar hyaluronic acid preparations. Furthermore, in the results after 24 weeks of re-administration, it showed even better improvements compared to the control group, and no serious adverse reactions were observed.
Osteoarthritis (OA) of the knee.
Intended Purpose: The product is used to relieve pain of osteoarthritis of the knee.
Patient Target Group: It is used for patients who do not get adequate pain relief from simple pain relievers like acetaminophen or from exercise and physical therapy.
Recommended Dose: The recommended treatment regimen is 2 mL (single-dose) injection in the knee.
Injection interval (more than 6 months after the last injection is recommended) should be carefully considered according to the patient's symptoms.
Administration: The product is injected into the knee joint and is administrated as a single intra-articular injection.
The product should not be used in infected or severely inflamed joints or in patients having skin diseases or infections in the area or the injection site.
Do not use in patients with hypersensitivity to any components in this product.
Do not use for pregnant women, lactating mother and children.
Do not use in patients with rheumatoid arthritis.
Do not use for other intended use.
Do not inject intravascularly.
The healthcare professional should read and understand the instruction for use (IFU) of the product.
Injection technique involves the risk of infection, so aseptic administration technique and standard procedure must be followed to prevent cross infection.
In order to minimize the risk of potential complications, this product should only be used by orthopedist or related to the doctor who have appropriate experience, and who are knowledgeable about the anatomy at and around the site of injection.
Orthopedist or related to the doctor, should use the new sterilized gloves when handling this product.
STERILE CONTENTS ARE GEL AND NEEDLE. EXTERIOR OF SYRINGE AND NEEDLE CASE/HUB CAP ARE NOT STERILE. Therefore, do not use if the packaging (syringe, needle) is opened or damaged.
This product is used for single use. Do not re-use or re-sterilize the remaining gel, syringe and needle to prevent the cross-infection.
This product is a colorless gel, so do not use it, if it has discoloration or foreign substances are identified.
Sharpness of needle can cause physical injury, so waste the used needle in the disposal container immediately after use.
Along with its intended effects, this product may cause some unintended effects. Although all of these adverse events may occur rarely, if they do occur they may need medical attention.
Local reactions at the injection site may occur such as discomfort, transient pain (i.e. arthralgia, myalgia,…) and transient increase of joint inflammation right after or within 48 hours after injection, joint swelling, joint effusion, redness, warm feeling and local allergic reaction. These side effects are generally of mild to moderate intensity and resolve spontaneously within a few days.
Check if any of adverse events persist.
"Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established".
Do not concomitantly use disinfectants containing quaternary ammonium salts for skin preparation because hyaluronic acid can precipitate in their presence.
Intended User: Only use by an orthopedist or related doctor.
Instruction for Use: Before the Use: The gel of the syringe must be used immediately after its packaging is opened.
The injection site should be disinfected with alcohol or other appropriate disinfection solution that isn't containing quaternary ammonium salts prior to administration.
Use a 23G needle packed in the blister. Do not use if the package of needle is damaged.
To ensure a tight connection and prevent leakage during administration, secure the needle and syringe tightly. If improper connection is made, it may burst and injure the user.
Do not over tighten or apply excessive leverage when attaching the needle or removing the needle case, as this may break the syringe tip.
Carefully push the plunger rod until a small droplet is visible at the tip of the needle before product injection to check if the needle is clogged. If the needle is clogged, do not use the product. If a clogged needle is used, an injury may occur on account of damage of the syringe.
Remove synovial fluid or effusion before injecting the product, if needed.
Directions for Assembly: Hold the luer-lock adapter of the prefilled syringe with one hand, and hold the syringe cap with the other hand.
Remove the syringe cap by turning it counterclockwise.
*Note: Do not grasp the body of the syringe when removing the syringe cap as there is a risk of breakage.
Remove the needle hub cap by turning it counterclockwise.
Note: Be careful not to touch the needle and syringe inlet to maintain sterility after detachment.
Secure the syringe barrel and luer-lock adapter firmly using thumb and index finger. Insert the screw thread of the needle firmly into the syringe and connect them while screwing clockwise the needle case which is holding with the other hand.
*Note: Do not grasp the body of the syringe when assembling the needle as there is a risk of breakage. Connecting the needle while holding the syringe body may cause a spinning with no traction, and leakage may occur when using an incomplete assembly.
Remove the needle case before injection.
After the Use: The used syringe, needle and remaining gel are disposed to according to healthcare waste management procedure (i.e., national or local regulations) after use.
Store in original packaging at 1 to 30°C.
Do not freeze.
Protect from direct sunlight.
Keep dry.
Shelf Life: 3 years from manufacturing date.
M09AX01 - hyaluronic acid ; Belongs to the class of other drugs for disorders of the musculo-skeletal system.
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