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					- - - - - - - - - - - - - - - - MATERIAL SAFETY DATA SHEET - - - - - - - - - - - - - - Pharmacia & Upjohn
LAST REVISED: 26 October 98 ----------------------------------------------------------1. CHEMICAL PRODUCT AND COMPANY IDENTIFICATION ----------------------------------------------------------COMMON NAME: NEOSAR(R) FOR INJECTION SYNONYMS: 0013-5606-93 - NDC NUMBER 0013-5616-93 - NDC NUMBER 0013-5626-93 - NDC NUMBER 0013-5636-70 - NDC NUMBER 0013-5646-70 - NDC NUMBER MOLECULAR FORMULA: Mixture CHEMICAL FAMILY: Nitrogen Mustard (Phosphoramide) USE: Human drug used in the treatment of various malignancies. MANUFACTURER/SUPPLIER: PHARMACIA & UPJOHN 7171 PORTAGE RD KALAMAZOO, MI 49001-0199 TELEPHONE NUMBERS: (616) 833-5122 - (24 HOURS) (616) 833-7555 - (8:00 a.m. - 4:30 p.m.) ----------------------------------------------------------2. COMPOSITION/INFORMATION ON INGREDIENTS ----------------------------------------------------------INGREDIENT 1: COMMON NAME: Cyclophosphamide % BY WEIGHT: 69% CAS NUMBER: 50-18-0 EXPOSURE LIMIT(S): Not established. INGREDIENT 2: COMMON NAME: Sodium chloride % BY WEIGHT: 31% CAS NUMBER: 7647-14-5 EXPOSURE LIMIT(S): Not established. EXPOSURE LIMIT(S) FOR THE MATERIAL: Not established. ----------------------------------------------------------3. HAZARDS IDENTIFICATION ----------------------------------------------------------PRIMARY ROUTE(S) OF EXPOSURE: Skin contact, eye contact, ingestion and inhalation. EFFECTS OF OVEREXPOSURE: Neosar is cytotoxic and will produce severe toxic effects to rapidly dividing tissues upon overexposure. Treatment with Neosar can cause nausea, vomiting, leukopenia, hair loss, significant suppression of immune response, secondary malignancies, adverse reproductive effects, including fetal harm and impairment of fertility, cardiac toxicity and hemorrhagic cystitis. MEDICAL CONDITIONS AGGRAVATED BY EXPOSURE: Not established. ----------------------------------------------------------4. FIRST AID MEASURES ----------------------------------------------------------EYES: Flush with water for 15 minutes. Hold eyelids open to assure complete contact with water. SKIN: Wash with soap and water. Remove contaminated clothing. INHALATION: Remove from exposure. Seek medical attention. INGESTION: Contact a physician or poison control center. ----------------------------------------------------------5. FIRE FIGHTING MEASURES ----------------------------------------------------------FLASH POINT: Not applicable (solid). LOWER EXPLOSION LIMIT (LEL): Not applicable. UPPER EXPLOSION LIMIT (UEL): Not applicable. EXTINGUISHING MEDIA: Water, carbon dioxide, or dry chemical. FIRE-FIGHTING PROCEDURES: Wear self-contained breathing apparatus and full body protective equipment. UNUSUAL FIRE OR EXPLOSION HAZARDS: As with all finely divided organic powders, it is advisable to eliminate explosion hazards by methods such as grounding mechanical equipment in contact with the material to prevent the buildup of static electricity, inerting the atmosphere or controlling dust levels. HAZARDOUS COMBUSTION PRODUCTS: Carbon monoxide. Carbon dioxide. Nitrogen oxides. Hydrogen chloride.

NEOSAR(R) FOR INJECTION
----------------------------------------------------------6. ACCIDENTAL RELEASE MEASURES ----------------------------------------------------------STEPS TO BE TAKEN IN CASE MATERIAL IS RELEASED OR SPILLED: Remove ignition sources; control the generation of dusts/vapors; provide ventilation and respiratory, skin and eye protection to prevent overexposure. Keep out of drains; prevent entry to surface water, groundwater and soil. Vacuum (with HEPA-filtered and explosion-proof equipment) or scoop spilled material and place in container. ----------------------------------------------------------7. HANDLING AND STORAGE ----------------------------------------------------------PRECAUTIONS FOR HANDLING AND STORING: Neosar is a potent anti-cancer drug. Caution in handling must be exercised. If powder or solution contacts the skin or mucosae, immediately wash thoroughly with soap and water. See product insert for further information. PRODUCT PREPARATION AND ADMINISTRATION: Personnel preparing or administering antineoplastic agents should wear double latex or surgical rubber gloves, safety glasses, a closed-front gown with knit cuffs and masks. Preparation of all antineoplastic agents should be done in a class II laminar flow biological safety cabinet with exhaust air discharged external to the room environment. All needles, syringes, vials, ampules and other equipment or disposable clothing which have been in contact with antineoplastic agents should be segregated and incinerated at a temperature not less than 1000 degrees centigrade. ----------------------------------------------------------8. EXPOSURE CONTROLS/PERSONAL PROTECTION ----------------------------------------------------------RESPIRATORY PROTECTION: Approved toxic dust mask or aerosol mask. VENTILATION: LOCAL EXHAUST: Vertical laminar flow hood. SPECIAL: HEPA filter vented to outside. PROTECTIVE GLOVES: Rubber. EYE PROTECTION: Splash goggles. OTHER PROTECTIVE EQUIPMENT: Long sleeved, impermeable disposable gown with elastic cuffs. ----------------------------------------------------------9. PHYSICAL AND CHEMICAL PROPERTIES ----------------------------------------------------------APPEARANCE/PHYSICAL STATE: White powder. MOLECULAR WEIGHT: Mixture. SOLUBILITY IN WATER: 40 GM/L ----------------------------------------------------------10. STABILITY AND REACTIVITY ----------------------------------------------------------STABILITY: Stable. PHYSICAL CONDITIONS TO AVOID: None known. INCOMPATIBILITY WITH OTHER MATERIALS: Benzyl alcohol preserved diluents. HAZARDOUS DECOMPOSITION PRODUCTS: None known. HAZARDOUS POLYMERIZATION: Does not occur. ----------------------------------------------------------11. TOXICOLOGICAL INFORMATION ----------------------------------------------------------ACUTE STUDIES: INTRAVENOUS LD50 (RAT): 148 MG/KG (Cyclophosphamide) ORAL LD50 (RAT): 160 MG/KG (Cyclophosphamide) INTRAPERITONEAL LD50 (RAT): 40 MG/KG (Cyclophosphamide) SUBCUTANEOUS LD50 (RAT): 144 MG/KG (Cyclophosphamide)

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- - - - - - - - - - - - - - - - MATERIAL SAFETY DATA SHEET - - - - - - - - - - - - - - Pharmacia & Upjohn
OTHER STUDIES: REPRODUCTION/FERTILITY: Cyclophosphamide interferes with oogenesis and spermatogenesis. It may cause sterility in both sexes. Sterility may be irreversible in some patients. TERATOGENICITY: Cyclophosphamide can cause fetal harm when administered to pregnant women. CARCINOGENICITY: Cyclophosphamide is listed as an IARC Group 1 Carcinogen (Carcinogenic to humans). It is listed as a carcinogen by NTP as a substance known to be carcinogenic to humans. ----------------------------------------------------------12. DISPOSAL CONSIDERATIONS ----------------------------------------------------------WASTE DISPOSAL METHOD: Mix with sodium hypochlorite. Dispose of by incineration in accordance with applicable international, national, state, and/or local waste disposal regulations. EPA WASTE CODE: U058. ----------------------------------------------------------13. SHIPPING REGULATIONS ----------------------------------------------------------REPORTABLE QUANTITY: 10 LBS (cyclophosphamide). Not regulated for transportation by the United States Department of Transportation (DOT), International Maritime Organization (IMO), or International Air Transport Association (IATA). May be subject to state and/or local transportation requirements. ----------------------------------------------------------14. OTHER INFORMATION ----------------------------------------------------------REVIEWED BY: Environment and Safety. ----------------------------------------------------------DISCLAIMER: The information contained in the MSDS is believed to be correct as of its date of issuance. BY MAKING THE MSDS AVAILABLE, PHARMACIA & UPJOHN DOES NOT MAKE ANY EXPRESS OR IMPLIED WARRANTY (INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE) REGARDING THE MSDS, ITS ACCURACY OR THE PRODUCT TO WHICH IT RELATES. Anyone using this information agrees that Pharmacia & Upjohn shall not be held liable (based on its negligence or otherwise) for any personal injury or other damage relating to, or arising from such use, including direct, incidental, or consequential damage and such user agrees to indemnify Pharmacia & Upjohn for any claims arising out of its use. ----------------------------------------------------------15. LABELING ----------------------------------------------------------This drug is subject to FDA labeling requirements; therefore, it is exempt from the labeling requirements of the OSHA Hazard Communication Standard. REVISION DATE: March 13, 1998 ----------------------------------------------------------DISCLAIMER OF EXPRESSED AND IMPLIED WARRANTIES: although preparer and owner have taken reasonable care in the preparation of this document, we extend no warranties and make no representation as to the accuracy or completeness of the information contained herein, and assume no responsibility regarding the suitability of this information for the user's intended purposes or for the consequences of its use. Each user should make a determination as to the suitability of the information for their particular purpose(s). A request has been made to the manufacturer to approve the contents of this material safety data sheet. Upon receipt of any changes a new MSDS will be made available. ----------------------------------------------------------COMPAS Code: 29300430

NEOSAR(R) FOR INJECTION

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