This is a definitive report.This case was reported from a hospital to chinese authority, and it was forwarded to manufacturer.The reporter did not provide any further information.According to the result of investigation, there were no deviations or out-of-specifications found in the manufacturing process, the in-process testing, the release testing, and the environmental monitoring for lot# 4c1g20.
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On (b)(6) 2022 a female patient of unknown age and weight of 62 kg was given artz dispo injection once a week for maintenance treatment due to "bilateral knee osteoarthropathy" after discharge.After she was discharged from the hospital, she developed a rash all over the body for unknown reasons, itching was unbearable, accompanied by scratches all over the body, so she went to the dermatology outpatient clinic.The doctor asked the patient's medical history and medication history, considering that it was an adverse drug reaction caused by sodium hyaluronate injection, and instructed the patient to stop the drug.On (b)(6) 2022 the patient returned to the outpatient clinic and complained that the rash symptoms were relieved but not cured after the drug was discontinued, and the sodium hyaluronate continued to be used due to the original disease, and the symptoms worsened again, which was more serious than before.
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