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美国FDA批准Zilletta(曲安奈德缓释注射混悬液)治疗骨关节炎(OA)膝关节疼痛(三)
2023-11-13 00:25:58 来源: 作者: 【 】 浏览:1604次 评论:0
                               梨醇酯-80,装在带橡胶塞、铝密封和白色
                                    塑料盖的玻璃小瓶中。
无菌小瓶适配器
存储器
为了保持有效期,在使用前将ZILRETTA单剂量试剂盒冷藏(36°-46°F;2°-8°C)。
如果无法冷藏,请将ZILRETTA单剂量试剂盒存放在密封的、未开封的试剂盒中温度不超过77°F(25°C)长达六周,然后丢弃。不要暴露ZILRETTA单剂量试剂盒,温度高于77°F(25°C)。不要冻结。将小瓶储存在纸箱中。
请参阅随附的ZILRETTA完整处方信息:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208845s011lbl.pdf
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ZilrettaTM for Osteoarthritis
Zilretta (triamcinolone acetonide extended-release injectable suspension) is a US Food and Drug Administration-approved treatment to manage osteoarthritis pain within the knee joint. It is available in 32mg (5ml)-dose vials.
Zilretta is the first and only FDA-approved treatment for osteoarthritic knee pain to employ extended-release microsphere technology. Microspheres are tiny particles invisible to the eye. The microspheres in Zilretta comprise a medicine called triamcinolone acetonide that assists in reducing the inflammation and pain caused by osteoarthritis. Once injected directly into the knee, the microspheres remain at the site, continually and slowly releasing medicine for about 3 months.
Disease Overview
Osteoarthritis of the knee is a degenerative joint disease that may lead to intermittent discomfort and ultimately to severe chronic pain, loss of function, and irreversible structural damage. The risk of osteoarthritis normally increases after age 45; however, it can also occur in younger individuals. The symptoms include stiffness, pain when moving the knee, crepitus (a crunching, creaking, or grinding sensation with movement), and swelling due to additional fluid in the joint.
Indications
Zilretta is indicated for the treatment of osteoarthritic knee pain that has not responded to traditional conservative treatments such as anti-inflammatory medications, physical therapy, activity modification, ice therapy, or immediate-release corticosteroid or hyaluronic acid injections.
Preparation
The pre-procedure preparation for the Zilretta intra-articular injection may involve the following:
A review of your medical history and a physical examinationRoutine blood work and imagingInforming your doctor about medications or supplements you are takingInforming your doctor about allergies to any medications, anesthesia, or latexDisclosing any recent illnesses or other medical conditionsRefraining from medications such as blood-thinners and nonsteroidal anti-inflammatories, or other supplements, if contraindicated for the procedureArranging for someone to drive you home after the procedure
Procedure
During the Zilretta intra-articular knee injection procedure, you will be seated or will lie on your back with the affected knee flexed or extended. The skin over the injection site is sterilized and numbed with a local anesthetic. A needle is inserted into your knee joint and the Zilretta medication is injected. In some cases, ultrasound imaging is used to help guide the nee
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