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Abciximab Solution
Material Safety Data Sheet
Effective Date: 19-Jan-2000
Section 1 - Chemical Product and Company
Manufacturer: Manufacturer's Emergency Phone:
Centocor B.V. (Leiden, The Netherlands), (610) 651-6000
a subsidiary of Centocor, Inc. CHEMTREC:
200 Great Valley Parkway 1-800-424-9300 (North America)
Malvern, PA 19355 1-703-527-3887 (International)
MSDS Prepared By:
Eli Lilly and Company
Lilly Corporate Center
Indianapolis, IN 46285
Phone: 1-317-276-2000
Common Name: Abciximab Solution
Synonym(s): Abciximab; Abciximab Injection; Monoclonal Antibody; Fab Fragment; 314366 Solution;
c7E3 Fab
Trademarks(s): ReoPro; ReoPro Injection; Centocor ReoPro
Lilly Item Code(s): VL7140; VL7141; VL7149
This vendor supplied document has been supplemented by Eli Lilly and Company using available
toxicological, physical, and other information.
See attached glossary for abbreviations.
Section 2 - Composition / Information on Ingredients
Ingredient CAS Concentration %
Abciximab 143653-53-6 NAIF
Water 7732-18-5 NAIF
This pharmaceutical preparation is a monoclonal antibody designed to inhibit platelet aggregation in the
blood during and after high-risk coronary angioplasty. It contains a protein of biological origin, a
chimeric (mouse and human) Fab fragment of a monoclonal immunoglobulin derived from a well
characterized cell-line, devoid of any pathogens, viruses, or host proteins. It is suspended in innocuous
buffers and salts.
This product contains no hazardous components as defined in OSHA 29 CFR 1910.1200.
Exposure Guidelines: Not established.
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Section 3 - Hazards Identification
Appearance: Clear fluid
Physical State: Liquid
Odor: Odorless
Emergency Overview
Emergency Overview Effective Date: 11-Feb-1995
Lilly Laboratory Labeling Codes:
Health 0 Fire 0 Reactivity 0
Primary Physical and Health Hazards: Not Considered a Health Hazard.
Caution Statement: Abciximab Solution is not considered to be a health hazard.
Routes of Entry: Skin contact.
Effects of Overexposure: Eye, no known hazard. Skin, no known hazard on intact skin or on cut or
abraded skin. Ingestion, not expected to be active orally. Inhalation, no known hazard.
Acute Effects - Pharmacologic effects of the drug (inhibition of platelet aggregation and increased
bleeding time) might be observed with a dose which approaches clinical levels (bolus dose 0.25 mg/kg
followed by an infusion at 10 ug/min for 12 hours). This would, in all likelihood, only be seen if the
entire amount was received over a short period of time.
Chronic Effects - No chronic occupational effects known.
Because the Fab protein is a chimeric murine-human immunoglobulin, there is a remote possibility that
a person with allergy to mouse protein might have an allergic reaction upon contact with this material,
such as in a cut, needlestick, eye or mucous membrane, or upon inhalation, with repeated exposures.
Medical Conditions Aggravated by Exposure: None known.
Carcinogenicity: Not listed by IARC, NTP, ACGIH, or OSHA.
Section 4 - First Aid Measures
Eyes: Immediately flush with water for 15 minutes. If irritation persists, seek medical attention.
Skin: Promptly wash with soap and water.
Inhalation: Obtain medical follow-up in the event of large exposures.
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Ingestion: Rinse mouth with water.
Notes to Physician: Consult the package insert for health effects details.
Section 5 - Fire Fighting Measures
Flash Point: Not applicable
UEL: Not applicable
LEL: Not applicable
Extinguishing Media: Use extinguishing agent which is suitable for the surrounding fire.
Unusual Fire and Explosion Hazards: Product presents no unusual hazard if involved in a fire.
Hazardous Combustion Products: None known.
Special Fire Fighting Procedures: None normally required.
Section 6 - Accidental Release Measures
Spills: Small Spill - Wear protective gloves. Absorb on suitable material, deposit in appropriate
container for disposal. Large Spill - Same as small spill. Avoid creating aerosols.
Section 7 - Handling and Storage
Shelf Life: 2.000000 Years at recommended storage temperature.
Storage Temp: 2.000000-8.000000 C Do not freeze.
Material Handling Precautions: Protect package from physical damage. Do not shake vials.
Section 8 - Exposure Controls / Personal Protection
See Section 2 for Exposure Guideline information.
Engineering Controls: Manufacturing and packaging operations should be designed to minimize
exposure to this material.
Respiratory Protection: Recommended for large spills and releases.
Eye Protection: Avoid eye contact. Eye protection required for spill clean up.
Other Protective Equipment: Avoid skin contact. Impervious protective gloves recommended for
use.
Additional Exposure Precautions: Avoid direct contact and significant aerosol exposure.
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Section 9 - Physical and Chemical Properties
Appearance: Clear fluid
Odor: Odorless
Boiling Point: No applicable information found
Melting Point: No applicable information found
Specific Gravity: 1.008
pH: 7.100000-7.200000
Evaporation Rate: No applicable information found
Water Solubility: Soluble
Vapor Density: No applicable information found
Vapor Pressure: No applicable information found
Section 10 - Stability and Reactivity
Stability: Chemically stable indefinitely.
Incompatibility: No dangerous chemical reactions known.
Hazardous Decomposition: None known.
Hazardous Polymerization: Will not occur.
Section 11 - Toxicological Information
Acute Exposure
Oral: No applicable information found.
Skin: No applicable information found.
Inhalation: No applicable information found.
Intravenous: Rabbit, 2mg/ml, no significant irritation.
Subcutaneous: Rabbit, 2mg/ml, no significant irritation.
Intramuscular: Rabbit, 2mg/ml, no significant irritation.
Skin Contact: No applicable information found.
Eye Contact: No applicable information found.
Chronic Exposure
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Target Organ Effects: No applicable information found.
Reproduction: No applicable information found.
Sensitization: No applicable information found.
Mutagenicity: Not mutagenic in mammalian cells.
Section 12 - Ecological Information
No applicable ecological information found.
Section 13 - Disposal Considerations
Waste Disposal: Dispose of as with any other prescription pharmaceutical product. Observe all federal,
state, and local regulations.
Section 14 - Transport Information
Regulatory Organizations:
DOT: Not Regulated
ICAO/IATA: Not Regulated
IMO: Not Regulated
Additional Information: USDA: Permit required for importation.
Section 15 - Regulatory Information
Below is selected regulatory information chosen primarily for possible Eli Lilly and Company
usage. This section is not a complete analysis or reference to all applicable regulatory
information. Please consider all applicable laws and regulations for your country/state.
U.S. Regulations
TSCA - No
CERCLA - Not on this list
SARA 302 - Not on this list
SARA 313 - Not on this list
OSHA Substance Specific - No
EU Regulations
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EC Classification
Not assigned an overall EC classification.
Section 16 - Other Information
Vendor MSDS Date: 08-Dec-1999
Additional Information: Report to the manufacturer any allegations of adverse effects resulting from
handling or accidental contact with this material.
Disclaimer - The information contained herein is based upon data considered true and accurate. To the
best of our knowledge, no occupational health hazards have been identified under normal conditions of
use, although the occupational health hazards of the product have not been thoroughly
investigated. Centocor makes no warranties, express or implied, as to the adequacy of the information
contained herein. This information is offered solely for the user's consideration, investigation, and
verification.
MSDS Sections Revised: Sections 1, 2, 3, 6, 9, 11, 12, and 15.
GLOSSARY:
ACGIH = American Conference of Governmental Industrial Hygienists
AIHA = American Industrial Hygiene Association
BEI = Biological Exposure Index
CAS Number = Chemical Abstract Service Registry Number
CERCLA = Comprehensive Environmental Response Compensation and Liability Act (of 1980)
CHAN = Chemical Hazard Alert Notice
CHEMTREC = Chemical Transportation Emergency Center
DOT = Department of Transportation
EC = European Community
EINECS = European Inventory of Existing Chemical Substances
ELINCS = European List of New Chemical Substances
EPA = Environmental Protection Agency
HEPA = High Efficiency Particulate Air (Filter)
IARC = International Agency for Research on Cancer
ICAO/IATA = International Civil Aviation Organization/International Air Transport Association
IEG = Lilly Interim Exposure Guideline
IMO = International Maritime Organization
Kow = Octanol/Water Partition Coefficient
LEG = Lilly Exposure Guideline
LEL = Lower Explosive Limit
MSDS = Material Safety Data Sheet
MSHA = Mine Safety and Health Administration
NA = Not Applicable, except in Section 14 where NA = North America
NADA = New Animal Drug Application
NAIF = No Applicable Information Found
NCI = National Cancer Institute
NIOSH = National Institute for Occupational Safety and Health
NOS = Not Otherwise Specified
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NTP = National Toxicology Program
OSHA = Occupational Safety and Health Administration
PEL = Permissible Exposure Limit (OSHA)
RCRA = Resource Conservation and Recovery Act
RQ = Reportable Quantity
RTECS = Registry of Toxic Effects of Chemical Substances
SARA = Superfund Amendments and Reauthorization Act
STEG = Lilly Short Term Exposure Guideline
STEL = Short Term Exposure Limit
TLV = Threshold Limit Value (ACGIH)
TPQ = Threshold Planning Quantity
TSCA = Toxic Substances Control Act
TWA = Time Weighted Average/8 Hours Unless Otherwise Noted
UEL = Upper Explosive Limit
UN = United Nations
WEEL = Workplace Environmental Exposure Level (AIHA)
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