Material Safety Data Sheet CISPLATIN INJECTION SECTION 2 COMPOSITION, INFORMATION ON INGREDIENTS

Transcription

1 Material Safety Data Sheet CISPLATIN INJECTION SECTION 1 - PRODUCT MSDS NAME: Cisplatin Injection, BP SYNONYMS: Cis-Diamminedi-chloroplatinum (II) SECTION 2 COMPOSITION, INFORMATION ON INGREDIENTS Active: Cisplatin Inactive: Sodium Chloride, Hydrochloric Acid,Sodium Hydroxide,Water for Injection SECTION 3 - HAZARDS IDENTIFICATION Route of Entry: Inhalation, eye/skin contact, or ingestion Caution should be exercised during handling. Cisplatin is a suspect carcinogen. Precautions that have been suggested include: use of a biological containment cabinet during reconstitution and dilution of parenteral medications, use of disposable surgical gloves and masks, use of proper technique to prevent contamination of medication onto the work area and operator, and proper disposal of needles, syringes, vials, and ampoules. SECTION 4 - EMERGENCY & FIRST AID MEASURES Eyes: Immediately flush eyes with copious quantities of water for at least 15 minutes. If pain, irritation, swelling, tearing persists after flushing, seek medical attention. Skin: Remove contaminated clothing and shoes. Wash skin with soap and plenty of water. If irritation occurs, seek medical attention. Inhalation: Move exposed subject to fresh air immediately. Give artificial respiration and Cardiopulmonary resuscitation (CPR) if required. Seek medical attention. Ingestion: Do not induce vomiting. If conscious, flush mouth with water. Seek medical attention. Do not give anything by mouth if person is unconscious.

2 SECTION 5 - FIRE FIGHTING MEASURES General Hazard: When heated to decomposition, toxic fumes may be emitted. Fire Fighting Evacuate the area. Water spray, foam or dry chemical extinguisher as Instructions: appropriate for surrounding fire and materials. Fire Fighting Firefighters should wear self-contained breathing apparatus and full Equipment protective equipment to avoid inhalation of smoke. Hazardous Combustion Emits toxic fumes of carbon monoxide, carbon dioxide, and oxides of Products: nitrogen SECTION 6 - ACCIDENTAL RELEASE MEASURES [ Wear recommended personal protective equipment (See Section 8 Exposure Controls/Personal Protection). Use absorbent towels or brooms to clean-up spill. Wipe surface area clean with soap and water. SECTION 7 - HANDLING AND STORAGE General Handling: When handling pharmaceutical products, avoid all contact with skin, eyes, nostrils, and mouth. Avoid inhalation of dust, fumes, mist, and/or vapors. Storage Conditions: Store at C (59-77 F). Do not refrigerate. Protect from light. SECTION 8 - EXPOSURE CONTROLS/PERSONAL PROTECTION Engineering Controls: General room ventilation is usually satisfactory. Use local exhaust ventilation if necessary. Personal Protective Equipment: Eye Protection: Safety glasses or chemical splash goggles recommended. Hand Protection: A double layer of disposable latex gloves is recommended. Respiratory NIOSH (National Institute for Occupational Safety and Health) Protection: approved respirator. Skin Protection: Disposable garments if direct skin contact is anticipated. Head cover, coverall, and long sleeves, protect exposed skin.

3 SECTION 9 - PHYSICAL AND CHEMICAL PROPERTIES Physical Form/ Appearance: This is a clear, slightly yellow, odorless liquid. Boiling Point: Approximately 100 C Molecular Weight: ph: Solvent Solubility: Soluble in water or saline SECTION 10 - STABILITY AND REACTIVITY Stability: Stable under most conditions. Conditions to Avoid: Protect from light. Do not refrigerate or freeze. Avoid contact with incompatible oxidizing agents of aluminum, sodium bicarbonate, sodium bisulfate, and sodium metabisulfate. Hazardous Polymerization: Will not occur SECTION 11 - TOXICOLOGY INFORMATION Signs & Symptoms of Exposure & Overexposure: This product is intended for therapeutic use only when prescribed by a physician. Potential adverse reactions from prescribed doses and overdoses are described the package insert. Adverse events from therapeutic doses include: nephrotoxicity, neuropathies, myelosuppression (leukopenia, thrombocytopenia, and anemia), fever, infection, nausea, vomiting, ototoxicity, tinnitis, hearing loss, deafness, and vestibular toxicity. Anaphylacticlike reactions of facial edema, bronchoconstriction, tachycardia, and hypotension have also been reported. Occupational exposure has not been fully investigated. Medical Conditions Aggravated by Accidental Exposure: Individuals with pre-existing renal impairment, myelosuppression, hearing impairment, or previous history of allergic reaction to cisplatin or other platinum containing compounds.

4 Acute Toxicity: Compound Type Route Species Dosage Cisplatin LD50 Oral Rat 28,500 mcg/kg LD50 Oral Mouse 32,700 mcg/kg LD50 SC Rat 8100 mcg/kg LD50 SC Mouse 16,900 mcg/kg LD50 SC Mouse 13 mg/kg LD50 IV Rat 8 mg/kg LD50 IV Mouse 11 mg/kg LD50 Intramuscular Rat 9200 mcg/kg LD50 Intramuscular Mouse 7900 mcg/kg LD50 - Mouse 10,900 mcg/kg Other: Pregnancy Category D: Cisplatin may cause fetal harm if administered to a pregnant woman. SECTION 12 - ENVIRONMENTAL IMPACT INFORMATION All work practices must be aimed at eliminating environmental contamination. ENVIRONMENTAL STABILITY: This product will be relatively stable under ambient environmental conditions. EFFECT OF MATERIAL ON PLANTS or ANIMALS: No specific information is currently available on the effect of Cisplatin on plants or animals in the environment. This product may be harmful or fatal to contaminated plant and animal life. Refer to Section 11 (Toxicological Information) for additional information on Cisplatin and its effects on test animals. SECTION 13 - TRANSPORTATION INFORMATION Not applicable. SECTION 14 - DISPOSAL INFORMATION Treatment, storage, transportation, and disposal must be in accordance with applicable to local, state, and other relevant regulations.

5 SECTION 15 - OTHER DATA The preceding information is based on available data and is believed to be correct. However, no warranty is expressed or to be implied regarding the accuracy of this information, the results to be obtained from the use there of or the hazards connected with the use of the material. Since the information contained herein may be applied under conditions beyond our control and with which we may be unfamiliar, INTAS does not assume any responsibility for the results of its use. This information is furnished upon the condition that the persons receiving it shall make their own determinations of the effects, properties, and protections, which pertain to their particular conditions.