ABSTRACT

Description: The active substance of Tecnemab K1 is a mixture of monovalent and bivalent antibody fragments [F(ab) and F (ab)2 fragments] derived from a murine IgG 2a monoclonal antibody raised against high molecular weight melanoma associated antigen (HMWMAA). HMW-MAA is a surface antigen associated with melanoma lesions. The product is provided as a kit containing 3×6 ml vials, each containing 0.35 mg of anti-HMW-MAA monoclonal antibody fragments. Additional ingredients include stannous chloride, human serum albumin, sodium tartrate, and potassium biphthalate. Also included in the kit are 3×1 ml ion exchange columns. When used, the antibody fragments are labeled with the 99mTc radioisotope, which is not supplied with the kit. Immedi-ately before use, the separately purchased 99mTc is coupled to the antibody fragments, followed by separation of free from bound radioactivity using the ion exchange columns.