General Information
Revision date
2016-03-06
Product name
Hyaluronidase, 80 U/mL in HEPES-HTF
1.2.1 Relevant identified uses
SAGE In Vitro Fertilization
Manufacturer Name
SAGE In Vitro Fertilization
Icons in SDS
Company Information
company name
SAGE In Vitro Fertilization
Section 2
SECTION 2: Hazards identification
Product contains the aminoglycoside, gentamicin sulfate. This broad spectrum antibiotic has been associated with nephrotoxicity and/or ototoxicity when administered I.V. and serum concentrations are maintained at static levels above 10 mg/mL for extended periods.
Contains
5.0 mg/mL human serum albumin, a derivative of human blood and a potentially biohazardous material. All donors used in its manufacture were individually tested and found to be nonreactive for hepatitis B surface antigen (HBsAg) and antibodies to hepatitis C virus (HCV) and human immunodeficiency virus (HIV) by approved testing methods. Donors of the source material have been screened for Creutzfeldt- Jakob disease (CJD). Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of CJD is also considered extremely remote. No cases of transmission of viral disease or CJD have ever been identified for albumin. All Bovine glands, organs and tissue raw materials used for further processing originate from certified USDA inspected plants, where animals are given ante- and post-mortem inspections and are deemed fit for human consumption.
