===================== Product Identification =====================
MSDS NAME:CYTOXAN TABLETS 50 MG
NIIN:00-733-5246
MSDS Number: BWKWP
=== Responsible Party ===
Company:BRISTOL-MYERS SQUIBB, PHARMACEUTICAL GRP
Address:5 GORDIS RD BLDG 124
Box:191
City:NEW BRUNSWICK
State:NJ
ZIP:08903-5000
Country:US
Info Phone Num:800-332-2056/908-519-3843
Emergency Phone Num:908-519-3843/609-921-4081
CAGE:BRIST
=== Contractor Identification ===
Company:BRISTOL-MYERS SQUIBB PHARMACEUTICAL GROUP
Box:191
City:NEW BRUNSWICK
State:NJ
ZIP:08903
Country:US
Phone:908-519-2385
CAGE:BRIST
Company:E R SQUIBB MEDATOPE DIV
Address:5 GORDIS RD BLDG 124
Box:191
City:NEW BRUNSWICK
State:NJ
ZIP:08903
Country:US
Phone:609-921-4081
CAGE:4T649
============= Composition/Information on Ingredients =============
Name:CYCLOPHOSPHAMIDE HYDRATE (SUSPECTED HUMAN CARCINOGEN BY
IARC - GROUP 1) *94-4*
CAS:6055-19-2
RTECS #:RP6157750
Fraction by Wt: 9%
Name:LACTOSE
CAS:63-42-3
RTECS #:OD9625000
Fraction by Wt: >1%
Name:STARCH; VANCIDE MZ-96
CAS:9005-25-8
RTECS #:GM5090000
Fraction by Wt: >1%
Other REC Limits:NUISANCE PARTICULATE
OSHA PEL:15 MG/CUM TOTAL DUST
ACGIH TLV:10 MG/CUM TOTAL DUST
Name:GUM ARABIC (ACACIA) *94-4*
CAS:9000-01-5
RTECS #:CE5945000
Fraction by Wt: >1%
Name:STEARIC ACID
CAS:57-11-4
RTECS #:WI2800000
Fraction by Wt: >1%
ACGIH TLV:10 MG/CUM
Name:TALC (POWDER), (ASBESTOS FREE), TALCUM; HYDROUS MAGNESIUM
SILICATE
CAS:14807-96-6
RTECS #:WW2710000
Fraction by Wt: >1%
OSHA PEL:2 MG/CUM
ACGIH TLV:2 MG/CUM (RESP DUST)
Name:MAGNESIUM STEARATE
CAS:557-04-0
RTECS #:WI4390000
Fraction by Wt: 1%
ACGIH TLV:10 MG/CUM
Name:FD & C BLUE NO. 1
CAS:3844-45-9
RTECS #:BQ4725000
Fraction by Wt: <1%
Name:D&C YELLOW NO. 10; ALUMINUM LAKE
CAS:8004-92-0
RTECS #:GC5796000
Fraction by Wt: <1%
===================== Hazards Identification =====================
LD50 LC50 Mixture:ORAL LD50 (RAT): 94 MG/KG
Routes of Entry: Inhalation:YES Skin:YES Ingestion:YES
Reports of Carcinogenicity:NTP:NO IARC:YES OSHA:NO
Health Hazards Acute and Chronic:INGESTION/INHALATION: DELAYED BONE
MARROW SUPPRESSION/CARDIOTOXICITY/SYSTEMIC ABSORPTION. SKIN:
SYSTEMIC ABSORPTION/MILD IRRITATION/SENSITIZATION. EYES:
CONJUNCTIVITIS. REPEATED SYSTEMIC EXPOSURE MAY CAUSE REVERSIBLE
BONE MARROW SUPPRESSION/GI EFFECTS/KIDNEY DAMAGE/PULMONARY
FIBROSIS/CARDIOTOXICITY. (SEE SUPP)
Explanation of Carcinogenicity:SEE INGREDIENTS
Effects of Overexposure:IRRITATION, NAUSEA, VOMITING, ANOREXIA,
DIARRHEA, HEADACHE, DIZZINESS, RASH, CYSTITIS, ALOPECIA, CHANGES IN
METABOLISM.
Medical Cond Aggravated by Exposure:LOW PLATELET/LEUKOCYTE COUNTS,
COAGULATION DISORDERS, RENAL/PULMONARY/CARDIAC DISEASE.
======================= First Aid Measures =======================
First Aid:INGESTION: INDUCE VOMITING IF CONSCIOUS & NOT CONVULSIVE.
NEVER GIVE ANYTHING BY MOUTH TO AN UNCONSCIOUS PERSON. SKIN:
IMMEDIATELY FLUSH W/LARGE AMOUNTS OF WATER. USE SOAP IF AVAILABLE.
EYES: FLUSH W/ PLENTY OF WATER FOR 15 MINS. OBTAIN MEDICAL
ATTENTION IN ALL CASES. NOTE TO PHYSICIANS: WHEN ADMINISTED
PARENTERALLY, IT IS A HIGHLY TOXIC DRUG W/A LOW THERAPEUTIC INDEX.
(SEE SUPP)
===================== Fire Fighting Measures =====================
Extinguishing Media:WATER, CO2, FOAM, DRY CHEMICAL.
Fire Fighting Procedures:WEAR SCBA, FLAME & CHEMICAL RESISTANT
CLOTHING/BOOTS/GLOVES. EVACUATE PERSONNEL UPWIND DIRECTIONS. REMOVE
UNNEED MATERIAL & COOL W/WATER FROM MAXIMUM DISTANCE.
Unusual Fire/Explosion Hazard:FINE POWDERS ARE CONSIDERED TO BE
COMBUSTIBLE.
================== Accidental Release Measures ==================
Spill Release Procedures:ISOLATE AREA & WEAR SUITABLE PROTECTIVE
CLOTHING. COLLECT MATERIAL W/MOIST PAPER TOWELING TO MINIMIZE DUST
GENERATION. CLEAN AREA W/DETERGENT & WATER. TREAT PRODUCT &
CONTAMINATED MATERIALS AS HAZARDO US & PLACE IN SUITABLE CONTAINER
FOR DISPOSAL.
====================== Handling and Storage ======================
Handling and Storage Precautions:STORE AT/BELOW 77F.
Other Precautions:AVOID INHALATION, INGESTION, SKIN/EYE CONTACT
W/CRUSHED/BROKEN TABLETS.
============= Exposure Controls/Personal Protection =============
Respiratory Protection:WEAR APPROVED DUST RESPIRATORS W/HIGH EFFICIENCY
PARTICULATE FILTERS/CARTRIDGES WHEN HANDLING LARGE QUANTITIES OF
BROKEN/CRUSHED TABLETS IN ABSENCE OF SUITABLE EXHAUST VENTILATION.
Ventilation:BIOLOGICAL SAFETY CABINET SHOULD BE USED FOR PREPARATION OF
THIS DRUG. LOCAL MECHANICAL EXHAUST IS RECOMMENDED.
Protective Gloves:DISPOSABLE LATEX SURGICAL
Eye Protection:CHEMICAL SAFETY GOGGLES
Other Protective Equipment:IMPERVIOUS DISPOSABLE COVERALLS W/CLOSED
FRONT, LONG SLEEVES & ELASTIC CUFFS, BOOTS.
Work Hygienic Practices:REMOVE/LAUNDER CONTAMINATED CLOTHING & SHOES
BEFORE REUSE. WASH HANDS AFTER HANDLING/BEFORE EATING/SMOKING/USING
TOILET.
Supplemental Safety and Health
SOLUBILITY: 40 MG/ML FOR CYCLOPHOSPHAMIDE MONOHYDRATE. HEALTH HAZARDS
CONT'D: THIS DRUG MAY BE HARMFUL TO FETUS. NOTE TO PHYSICIANS
CONT'D: CYCLOPHOSPHAMIDE IS A HUMAN CARCINOGEN/POSSIBLE TERATOGEN &
REPRODUCTIVE TOXIN. THOSE W/HEART FAILURE/IMPAIRED RENAL-LIVER
FUNCTIOIN/RECENT RADIATION/CHEMOTHERAPY AT INCREASED RISK
================== Physical/Chemical Properties ==================
Melt/Freeze Pt:M.P/F.P Text:105.8-113F
Solubility in Water:(SEE SUPP)
Appearance and Odor:ROUND, BICONVEX & WHITE TABLETS W/BLUE FLECKS
MARKED W/EITHER 25/50 FOR STRENGT
================= Stability and Reactivity Data =================
Stability Indicator/Materials to Avoid:YES
STRONG OXIDIZERS.
Stability Condition to Avoid:TEMPS >77F.
Hazardous Decomposition Products:CO, CO2, CHLORIDE, HYDROGEN CHLORIDE,
NITROGEN OXIDES, PHOSPHORUS OXIDES, PHOSPHINE.
Conditions to Avoid Polymerization:TEMPS >120F.
==================== Disposal Considerations ====================
Waste Disposal Methods:SHOULD BE INCINERATED AT AN APPROVED FACILITY
IAW/FEDERAL, STATE, LOCAL & COUNTY REGULATIONS. EPA WASTE NO.:
U058.
Disclaimer (provided with this information by the compiling agencies):
This information is formulated for use by elements of the Department
of Defense. The United States of America in no manner whatsoever,
expressly or implied, warrants this information to be accurate and
disclaims all liability for its use. Any person utilizing this
document should seek competent professional advice to verify and
assume responsibility for the suitability of this information to their
particular situation.
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