Carboplatin Injection

Teva Sicor Pharmaceuticals, Inc

Revision date : 2005-11-20

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Note: Ingredients listed on restricted chemical lists

EC/CAS

7732-18-5

Name of the chemical

Water, distilled, conductivity or of similar purity H2O

Concentration

N/A

General Information

Revision date

2005-11-20

Product name

Carboplatin Injection

Product Synonyms

Paraplatin® Platinum, diammine [1,1-cyclobutanedicarboxylato(2-)-0,0`]-(SP-4-2)

Chemical name

Platinum, diammine [1,1-cyclobutanedicarboxylato(2-)-0,0`]-(SP-4-2)

1.2.1 Relevant identified uses

Medical Treatment; Ovarian Carcinoma

Manufacturer Name

Teva Sicor Pharmaceuticals, Inc

Emergency telephone

1-800-424-9300, 1-202-483-7617, 1-800-729-9991

Icons in SDS

M004 M009 M010 M011 M013 M017 M059

Company Information

company name

Teva Sicor Pharmaceuticals, Inc

Section 2

SECTION 2: Hazards identification

2. COMPOSITION AND INGREDIENTS CHEMICAL NAME CAS# EXPOSURE LIMITS IN AIR Wt% ACGIH OSHA Other TLV CEIL PEL CEIL Carboplatin (exposure limit for 41575-94-4 1 0.002 mg/m3 NE 0.002 mg/m3 NE 0.002 mg/m3* Platinum, soluble salts as Platinum) Water (for injection) 7732-18-5 99 NE NE - Not Established C - Ceiling Limit *NIOSH REL NOTE: All WHMIS required information is included. It is located in appropriate sections based on the ANSI Z400.1 – 1998 format CHEMTREC NUMBER: Use only in the event of a chemical emergency involving a spill, leak, fire, exposure or accident involving this drug. EMERGENCY OVERVIEW: Material is a clear, colorless solution. Toxic if injected or swallowed. Eye irritant. May cause damage to the kidneys, bone marrow, blood, liver, nervous and gastrointestinal systems. Harmful to the fetus. May cause allergic skin and/or respiratory reactions. Avoid contact with eyes, skin and clothing. Avoid exposure during pregnancy and while breastfeeding. Do not taste or swallow. Wash thoroughly after handling. 1 3. HAZARD IDENTIFICATION cont… Symptoms of Overexposure by Route of Exposure: This material is intended for intravenous injection under the supervision of physicians. Inhalation: Inhalation of significant amounts of the product is not anticipated to occur because of the small size of individual containers. Contact with Skin or Eyes: Contact may cause irritation. Effects may include stinging, watering, Injection redness and swelling of the eyes and redness and a burning sensation. Ingestion: Ingestion is not an anticipated route of occupational exposure. However, the active ingredient, Carboplatin, is toxic if swallowed. Symptoms similar to those identified under injection may occur. Injection: Local redness and pain are the primary symptoms of accidental injection in an occupational setting. Medical personnel are not anticipated to experience over-exposures to the therapeutic doses of this product. However, effects including decreased blood platelets, granulocytes and white blood cells, fever, anemia, nausea, vomiting, abdominal pain, diarrhea, constipation, peripheral neuropathy, visual disturbances, change in taste, abnormal renal and liver function tests, decreased serum electrolytes, rash, hives, redness, itching, hearing loss, vision changes, bronchospasms and decreased blood pressure may occur. Severe injection overexposure may be fatal. See package insert for other adverse reactions associated with therapeutic doses of this product. Health Effects or Risks From Exposure (An explanation in lay terms): Carboplatin Acute: The primary health effects anticipated in an occupational setting include irritation of eyes and skin as well as redness and local swelling after accidental injection. In case of over-exposure by injection, effects such as anemia, nausea, vomiting, abdominal pain, diarrhea and constipation may occur. Cancer: Carboplatin has not been tested in laboratory animals. However, it is considered possibly carcinogenic (see Section 11). Chronic: Based on animal data, Carboplatin, is considered a potential reproductive and developmental toxicant (see Section 11). Target Organs: Potential hazard to the kidneys, bone marrow, blood, liver and nervous systems (see Section 11). Pre-Existing Medical Conditions: Pre-existing kidney, bone marrow, blood, liver and nervous systems disorders may be aggravated by exposure to this material. 2

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