Tretten , Coagulation Factor XIII A-Subunit (Recombinant)

SECTION 2: Hazards identification

WHMIS 2015 Classification of the chemical The powder is white (lyophilized powder) and the solvent is clear and colorless

Signal word

Not required

Hazard statements

Not required

Precautionary statements

Not required

Other hazards which do not result in classification

No special risk if used in accordance with the instructions of the supplier. Tretten is used for the long-term prevention of bleeding in adults and children aged six and over. Tretten is a recombinant coagulation factor XIII A-subunit produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology.

2.1 Classification of the substance or mixture

The powder is white (lyophilized powder) and the solvent is clear and colorless. This material is not classified as hazardous under U.S. OSHA regulations (29CFR 1910.1200) (Hazcom 2012) and Canadian WHMIS regulations (Hazardous Products Regulations) (WHMIS 2015). This document has been prepared in accordance with standards for workplace safety, which require the inclusion of all known hazards of the product or its ingredients regardless of the potential risk. Your needs may vary depending upon the potential for exposure in your workplace. The precautionary statements, warnings and hazards included herein may not apply in all cases, such as when the product or device is in its final form and being used to treat the approved medical condition(s) while under the care of a licensed medical professional and in accordance with the FDA-approved Prescribing Information. Refer to FDA-approved Prescribing Information for final marketed products with regard to special storage, handling and administration requirements in the clinical setting.