Hyruan One Special Precautions

General precaution: Administration of Hyruan ONE to severely inflamed joints caused by deformative osteoarthritis can lead to exacerbation of local inflammation symptoms. Thus, Hyruan ONE is desired to be given after the removal of existing inflammation symptoms.
Administration of Hyruan ONE may occasionally cause local pain or swelling. Thus, patients should be informed to avoid strenuous exercise or actions leading joint pain of knee up to 48 hours after administration, and action such as local relaxation should be guided after injection.
Leakage of Hyruan ONE outside the articular cavity might cause pain. Thus, Hyruan ONE should be accurately injected into the articular cavity.
Precaution in use: Hyruan ONE should be administered by a doctor fully trained for the treatment.
Since Hyruan ONE is injected directly into the joints, administration should be performed under intact sterilization status.
In case of retention of articular fluid, the fluid should be removed by puncturing prior to administration of Hyruan ONE.
Intravascular injection, extra-articular injection, or injection into the synovial tissues should be avoided.
It is desirable to administer the product using an enclosed needle.
Care should be taken with a disinfectant quaternary ammonium salt such as benzalkonium chloride and chlorhexidine which may induce precipitation of hyaluronic acid.
Hyruan ONE is intended for single use only. Re-use or re-sterilization of the product is prohibited since the sterility will be compromised which may lead to adverse events.
The injection site must be sterilized either by alcohol or other disinfecting solution prior to administration.
Used syringe, needle, and unused materials all need to be discarded after administration.
In case Hyruan ONE is administered into both knees a separate product should be applied for each administration.
Clinical safety and effectiveness for pregnancy, nursing mothers, and pediatrics have not been established.
Since a physiological function of geriatrics has generally declined, treatment should be made carefully.