Atri ONE Special Precautions

General Precautions: Administration of this product to severely inflamed joints caused by deformative osteoarthritis can lead to exacerbation of the local inflammation symptoms. Thus, this product is desired to be given after the removal of existing inflammation symptoms.
Administration of this product may occasionally cause local pain, erythema, or swelling, therefore patients should be informed to avoid strenuous exercise or action leading to joint pain of knee up to 48 hours after administration, and actions such as local relaxation should be guided after injection.
Leakage of this product at an area other than articular cavity might cause pain; therefore this product should be accurately injected into articular cavity.
This product should be administered by a medical professional.
Precautions in Use: Since this product 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 this product, if necessary.
Intravascular injection, extra-articular injection or injection in the synovial tissues should be avoided.
It is desirable to administer the product using enclosed needles.
Care should be with a disinfectant fourth-grade ammonium salt such as benzalkonium chloride and chlorohexidine.
This product is intended for single use only. No re-sterilization or reuse is allowed. Do not use if packaging or syringe is opened or damaged.
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 this product is injected into both knees, a separate product should be used for each administration.
Do not re-administer if symptoms do not improve.
Precautions in Handling: This product should be kept in original packaging; storing this product in a different packaging can cause misuse of product or decline the product quality.
Effects on ability to drive and use machine: Not applicable.
Use in Pregnancy & Lactation: See USE IN PREGNANCY & LACTATION section for further information.
Use in Children: The pediatric safety and efficacy of this product have not been established, therefore administration of this product to pediatrics is not recommended.
Use in the Elderly: Since physiological function of geriatrics has a declining tendency, administration should be made carefully. In two clinical trials, subjects aged 65 years or older who received this product were 55.4% (118/213 subjects) of the total subjects, and there was no difference in response to the drug between the elderly and non-elderly subjects.