Note: Ingredients listed on restricted chemical lists
EC/CAS
61791-12-6
Name of the chemical
polyethyleneglycol ester of castor oil
Concentration
151-7
EC/CAS
201-069-1/77-92-9
Name of the chemical
Citric acid
Concentration
Proprietary
EC/CAS
200-578-6/64-17-5
Name of the chemical
Ethanol
Concentration
Proprietary
General Information
Revision date
2015-01-04
Product name
PACLITAXEL INJECTION, USP
Product Synonyms
NDC 45963-613-56: 30 mg/5 mL multi-dose vial individually packaged in a carton; NDC 45963-613-53; 100 mg/16.7 mL multi-dose vial individually packaged in a carton;
supplier name
U.S
Emergency telephone
1-800-424-9300, +1-703-527-3887
Icons in SDS
Company Information
company name
ACTAVIS, INC
e-mail address of the competent person responsible for the Safety Data Sheet
SDS@Actavis.com
Section 2
SECTION 2: Hazards identification
Product definition
This product is a clear, colorless to slightly yellow viscous solution
Health hazards
WARNING! THIS PRODUCT CONTAINS A CYTOTOXIC AGENT. EXPOSURE BY ALL ROUTES OF EXPOSURE MUST BE AVOIDED. May be harmful if ingested, inhaled or in skin contact. In the workplace, exposure via inhalation and skin contact may cause irritation. Inhalation of vapors or accidental ingestion may cause adverse central nervous system effects, due Denatured Alcohol content. Eye contact can cause irritation. In therapeutic use, the most common adverse effects reported have been low red blood cell count (anemia) feeling weak or tired hair loss, numbness, tingling, or burning in your hands or feet (neuropathy), joint and muscle pain, nausea and vomiting, hypersensitivity reactions (trouble breathing; sudden swelling of your face, lips, tongue, throat, or trouble swallowing; hives (raised bumps) or rash, diarrhea, mouth or lip sores, infections, swelling of your hands, face, or feet, bleeding events, irritation and reaction at the injection site, low blood pressure. Allergic reaction, including anaphylaxis, may occur and be severe; no information is available that workplace exposure can cause reactions. May harm cause to the fetus, based on animal information. Limited evidence of mutagenic effects and adverse effects on fertility for both genders, based on animal data. 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 product is flammable and can ignite if exposed to high temperature, an ignition source or direct flame. When involved in a fire, this product may ignite and produce irritating vapors and toxic compounds (including carbon and nitrogen oxides).
Environmental hazards
The active ingredient of this product is harmful to aquatic organisms and may cause harm to animals and aquatic organisms if accidentally released to the environment. Emergency Recommendations: Emergency responders must wear personal protective equipment suitable for the situation to which they are responding.
