|
- 现金
- 62111 元
- 精华
- 26
- 帖子
- 30437
- 注册时间
- 2009-10-5
- 最后登录
- 2022-12-28
|
本帖最后由 StephenW 于 2011-10-12 14:48 编辑
FDA Approves Pegasys Autoinjector for Hepatitis C Patients
Details Category: HCV Treatment
Published on Tuesday, 11 October 2011 00:00 Written by Press Release
The U.S. Food and Drug Administration (FDA) recently approved an autoinjector for pegyalted interferon alfa-2a, which will make it more convenient for hepatitis C patients to self-administer the medication.
美国食品和药物管理局（FDA）最近批准pegyalted干扰素α- 2a的自动注射器，这将使得C型肝炎患者自我管理服药更方便。
Below is an edited excerpt from an FDA announcement described the autoinjector.
Pegasys (peginterferon alfa-2a) New Disposable Autoinjector On September 29, 2011, the Food and Drug Administration approved a135 mcg/0.5 ml and 180 mcg/0.5 ml disposable autoinjector (DAI) to administer Pegasys (peginterferon alfa-2a), an antiviral indicated for treatment of chronic hepatitis C (CHC) by subcutaneous injection.
Pegasys continues to be available in a vial or prefilled syringe, and now also in a 135 mcg/0.5 ml and 180 mcg/0.5 ml Pegasys disposable autoinjector. The package insert and the Medication Guide have been updated to provide new information and instructions for use related to the disposable autoinjector.
Because the autoinjectors are designed to deliver the full content, autoinjectors should only be used for patients who need the full dose (180 or 135 mcg). If the required dose is not available in an autoinjector, prefilled syringes, or vials should be used to administer the required dose. The autoinjector is for subcutaneous administration only.
The updated label and Medication Guide can be found on the FDA web site at http://www.accessdata.fda.gov/dr ... /103964s5204lbl.pdf
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103964s5204lbl.pdf.
Pegasys is a product of Hoffmann-La Roche, of Nutley, NJ.
10/11/11
Source
R Klein and K Struble. Pegasys (peginterferon alfa-2a) new disposable autoinjector. FDA Hepatitis Update. October 7, 2011.
|
|
发表于 2011-10-12 14:45
