Hyruan III

Hyruan III

sodium hyaluronate

Manufacturer:

LG Chem Life Sciences

Distributor:

DKSH

Marketer:

LG Chem Life Sciences
Full Prescribing Info
Contents
Sodium hyaluronate.
Description
Hyruan III injection is a milestone viscosupplementation treatment used to relieve pain due to osteoarthritis of the knee and shoulder periarthritis. This viscoelastic supplement of intra-articular injection acts as a shock absorber and lubricant, and is used for patients who do not obtain adequate relief from analgesics or anti-inflammatory drugs, exercise, and physical therapy. Active ingredient of Hyruan III injection, sodium hyaluronate is one of the most important molecular components between the cells of all tissues of the human body and Hyruan III injection is an ethical drug designed to replace the diseased synovial fluid found in osteoarthritic knees and periarthritic shoulders.
1 mL of Hyruan III injection contains: Sodium Hyaluronate (EP) 10 mg.
Inactive Ingredients/Excipients: Isotonizer: Sodium Chloride 8.5 mg. pH adjusters: Dibasic Sodium Phosphate & Monobasic Sodium Phosphate. Solvent: Water for Injection.
Action
Pharmacology: Summary of the Clinical Study: A multicentre randomized, open-label, phase III study to compare the efficacy and safety of Hyruan III (high-molecular-weight hyaluronan) once a week for 3 weeks with Hyal (low molecular-weight hyaluronan) once a week for 3 weeks with Hyal (low molecular-weight hyaluronan) once a week for 5 weeks in patients with the knee osteoarthritis was conducted.
Efficacy result: 1) Primary efficacy variable: The statistical analysis of primary efficacy variable was based on the based on the comparison of improvement in pain intensity on weight bearing in the target knee. The results demonstrated the non-inferiority of Hyruan III injection as compared with Hyal injection for treatment of knee OA.
2) Secondary efficacy variables: WOMAC-Likert assessments: Both OA pain and functional disability, as compared with baseline, the score at each visit was significantly reduced in both treatment groups. Furthermore, chronological comparison of score in each group was also known to be statistically significant.
Patient's global assessment: Although patients of the Hyruan III group reported greater improvement of knee OA, the inter-group difference was not statistically significant.
Investigator's global assessment: Although investigator's assessments indicated greater improvement of knee OA in patients of the Hyruan III group, the inter-group difference was not statistically significant.
Evaluation of knee OA signs (Swelling, tenderness, range of motion, rescue medication usage).
The inter-group difference was not statistically significant.
Safety result: Adverse events: The percentage of patients with one or more adverse events was 68.4% in the Hyruan III group and 62.8% in the Hyal group. Pain at the injection site was the most common adverse event and was observed in a comparable number of patients in both treatment groups: 24 (30.4%) and 25 (32.1%) in the Hyruan III and Hyal groups, respectively. Adverse events observed in ≥5% of patients in at least one of the two treatment groups were: Myalgia (10.1% and 10.3% in the Hyruan III and Hyal groups, respectively), headache (6.3% and 11.5%), upper respiratory infection (7.6% and 3.8%), indigestion (7.6% and 2.6%) and rhinitis (0.0% and 5.1%). The general profile of adverse events was not significantly different between the two treatment groups.
Conclusion: The results of the present study indicate that the efficacy and safety of Hyruan III injection once a week for 3 weeks is comparable to Hyal injection once a week for 5 weeks.
Indications/Uses
Osteoarthritis of the knee and periarthritis of the shoulder.
Dosage/Direction for Use
In adults, Hyruan III injection is administered by intra-articular injection directly into the knee or shoulder once a week for three weeks, consecutively. Injection frequenct can be adjusted according to symptom and severity. Since Hyruan III injection is injected directly into synovial space, administration should be made strictly sterilized procedure.
Special Precautions
Hyruan III injection should not be administered in to following patients: Patients with a prior hypersensitivity to sodium hyaluronate.
Hyruan III injection should be administered with caution to following patients: 1) Patients with a prior hypersensitivity to other drugs.
2) Patients with liver disease or prior history of it (Abnormal AST, ALT have occurred in the patients with prior history of liver disease).
3) Patient with skin disease or infection at articular site to be injected.
General Precautions: It is strongly recommended that Hyruan III injection should be given only after the removal of inflammation caused by deformative osteoarthritis of the knee when administered into severely inflamed joints, because Hyruan III injection may exacerbate local inflammation symptom.
Since local pain can occasionally occur after administration of Hyruan III injection, it should be informed patients the local relaxation is recommended after administration.
Since pain can be caused by the leakage of Hyruan III injection out of articular cavity, it should be administered accurately into articular cavity.
Precautions in Usage: 1) Precaution at the time of injection: Since Hyruan III injection is injected directly into knee or shoulder, administration should be performed under strictly sterile manipulation.
In case no improvement in symptoms is obtained, administration of Hyruan III injection is restricted to three times.
In case retention of articular fluid occurs, the fluid should be pulled out by transition, if necessary.
2) Others: Hyruan III injection should not be introduced into blood vessel.
Hyruan III injection should not be used for opthalmological purpose.
Since Hyruan III injection is very viscous, it is desirable to use 22-23 G needle for administration.
Care should be taken because Hyruan III injection can cause precipitation by 4th grade ammonium salt such as benzalkonium chloride, bacterial disinfectant, etc. and chlorhexidine.
Use in Children: As pediatric safety has not been established, Hyruan III injection should be administered to children with caution when administered unavoidably.
Use in Elderly: Since physiological function of geriatrics has generally declined, administration should be made carefully.
Use In Pregnancy & Lactation
Administration to pregnant and nursing women: Since teratogenicity was denied in animal tests but safety in pregnant women has not been established, Hyruan III injection should be cautiously administered to pregnant women or women having possibility to be pregnant only when it is judged that benefits of treatment exceed a possibility of danger.
Since it has been proved Hyruan III injection is excreted into breast milk in animal tests, nursing should be avoided during the administration of it.
Adverse Reactions
Adverse Effects: Serious adverse effects: Shock: Since symptoms of shock (indistinct frequency) may occur, careful observation should be made. In case abnormalities are noticed, administration should be discontinued and proper measures should be taken.
Other Adverse Effects: Hypersensitivity: Edema (face, eyelid, etc.), facial flare, rarely rash, urticarial, pruritus, and so on may occur. In case these symptoms occur, administration should be discontinued and appropriate measures should be taken.
Articular Sites Injected: Occasionally pain (mainly transient pain after injection), swelling, rarely edema, flare, sense of heat, and sense of local oppression may occur.
Others: Nausea, vomiting and fever may occur.
Caution For Usage
Special Attention: Do not use if rubber cap of front part of syringe is open.
The syringe contents are for single use only.
Storage
Store at 2-8°C in the refrigerator, in light-resistant hermetic container.
Shelf-Life: 3 Years (36 Months).
ATC Classification
M09AX01 - hyaluronic acid ; Belongs to the class of other drugs for disorders of the musculo-skeletal system.
Presentation/Packing
Soln for inj (pre-filled syringe, clear colorless, viscoelastic) 2 mL x 3's.
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