FLUDARABINE PHOSPHATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

SECTION 2: Hazards identification

Product definition

This product is a white to off-white powder. Health Hazards WARNING! THIS PRODUCT CONTAINS A CYTOTOXIC AGENT. EXPOSURE BY ALL ROUTES MUST BE AVOIDED. In the workplace may be harmful by skin contact. Toxic by injection. May be harmful or fatal by inhalation and ingestion. There are scientific studies that suggest that personnel (e.g. nurses, pharmacists, etc.) who prepare and administer parenteral antineoplastics (e.g. in hospitals) may be at some risk due to potential mutagenicity, teratogenicity, or other reproductive effects of these materials if workplace exposures are not properly controlled. The actual risk in the workplace is not known. Therapeutic use can cause compromise of the immune system, cause depression of bone marrow, pulmonary toxicity, neurological toxicity, adverse central nervous system effects, rash, fever and eye infections, gastrointestinal, hematological, and hepatic effects and occasionally, cardiovascular effects. Fludarabine is a suspect mutagen and reproductive toxin for both genders, based on animal testing. May cause harm or be fatal to developing fetus. These effects may be possible as a result of workplace exposure. Refer to Section 11 (Toxicological Information) for additional information on adverse effects. Flammability Hazards: This compound requires substantial pre-heating before ignition occurs. As a finely-divided organic compound, the accumulation of dusts of this compound can create a serious hazard of explosion. When involved in a fire, this material may decompose and produce irritating vapors and toxic compounds (including carbon and nitrogen oxides, and hydrogen fluoride). Reactivity Hazards: This product is not reactive. Environmental Hazards: This product has not been tested for environmental harm; all release to the environment should be avoided. Emergency Recommendations: Emergency responders must wear personal protective equipment suitable for the situation to which they are responding.