General Information
Revision date
2016-04-04
Product name
In Vitro Maturation Kit, ART-1600
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 mcg/mL for extended periods. Contains 5 mg/mL plasma protein fraction 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 plasma protein fraction.
