New Instructions for Using Talecris IG Syringes

Talecris Biotherapeutics has revised the directions for administering some of the company's immune globulin products -- ones that come in uncalibrated prefilled 2 mL syringes with fixed needles. The products are HyperRAB™ S/D, which is an anti-rabies product, and GamaSTAN™ S/D, which is indicated for the prophylaxis of hepatitis A, measles and other infectious diseases.

In certain situations, the fixed needle and lack of graduation marks on the affected 2 mL syringes may make it difficult to administer the recommended dose. That can happen when a pediatric dose of less than 2mL is required, or when the dose is administered at more than one site or when using a needle size other than the one that's provided.

The company has sent out revised instructions on how to use the product properly under these circumstances or call the Talecris Biotherapeutics help line at 919-412-1030.

FDA Patient Safety News: May 2008

For more information, please see our website:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=75#5

Category:

Education

Tags:

• immune
• globulin
• measles
• IG
• hepatitis
• anti-rabies
• product
• talecris
• biotherapeutics