OXALIPLATIN INJECTION

TEVA

Revision date : 2012-08-06

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Health risk rating
Safety risk rating
Environmental risk rating

Note: Ingredients listed on restricted chemical lists

EC/CAS

231-791-2/7732-18-5

Name of the chemical

Water, distilled, conductivity or of similar purity H2O

Concentration

N/A

EC/CAS

200-559-2

Name of the chemical

Lactose C12H22O11

Concentration

N/A

General Information

Revision date

2012-08-06

Product name

OXALIPLATIN INJECTION

Chemical name

cis-[(1 R,2 R)-1,2-cyclohexanediamine-N,N"] [oxalato(2-)- O,O"] platinum Active Ingredient Organoplatinum Complex Antineoplastic 50 mg/10 mL, 100 mg/20 mL (5 mg/mL) Vials

1.2.2. Uses advised against

Other than Relevant Use

Manufacturer Name

TEVA

Emergency telephone

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

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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 a clear, colorless, odorless, aqueous solution. Health WARNING! CONTAINS A CYTOTOXIC AGENT. 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, and/or carcinogenicity of these materials if workplace exposures are not properly controlled. The actual risk in the workplace is not known. Exposure by all routes must be avoided. This product is harmful by ingestion. This product may be harmful by inhalation and may cause eye and skin irritation. May cause severe skin and respiratory allergic reactions. During therapeutic use the most common adverse effects have been peripheral sensory neuropathy, neutropenia, thrombocytopenia, anemia, nausea, increase in transaminases and alkaline phosphatase, diarrhea, emesis, fatigue and stomatitis. May cause harm to the fetus and adverse effects via lactation from nursing mothers who use it therapeutically. This product has potential carcinogenic and mutagenic effects and can cause damage to organs. See Section 11 (Toxicological Information) for information on other potential

Health hazards

known from therapeutic use. Flammability Hazards This product 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 and platinum compounds). Reactivity Hazards: This product is not reactive. Environmental This product 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.

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