FLUDARABINE PHOSPHATE INJECTION

TEVA

Revision date : 2012-06-05

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Health risk rating
Safety risk rating
Environmental risk rating

Note: Ingredients listed on restricted chemical lists

EC/CAS

200-711-8/69-65-8

Name of the chemical

D-mannitol C6H14O6

Concentration

proprietary

EC/CAS

231-791-2/7732-18-5

Name of the chemical

Water, distilled, conductivity or of similar purity H2O

Concentration

Balance

General Information

Revision date

2012-06-05

Product name

FLUDARABINE PHOSPHATE INJECTION

Chemical name

9H-Purin-6-amine, 2-fluoro-9-(5-O-phosphono-β-D-arabinofuranosyl)

Manufacturer Name

TEVA

Emergency telephone

1-800/424-9300, 01-703-527-3887

Icons in SDS

Company Information

company name

TEVA

e-mail address of the competent person responsible for the Safety Data Sheet

bernadette.pogozelski@tevapharm.com

Section 2

SECTION 2: Hazards identification

Product definition

This product is clear, colorless, odorless liquid. Health Hazards WARNING! THIS PRODUCT CONTAINS A POWERFUL CYTOTOXIC AGENT. EXPOSURE BY ALL ROUTES OF EXPOSURE MUST BE AVOIDED. Toxic by injection. May be harmful or fatal by inhalation and ingestion. May be harmful by skin contact. 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, based on animal testing. May cause harm or be fatal to developing fetus. Flammability This solution is not flammable or combustible. When involved in a fire, this material may decompose and produce irritating vapors and toxic compounds (including carbon and nitrogen oxides). 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.

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