Monoclate-P 庐
Material Safety Data Sheet
Effective Date: 07/20/00 Date Printed: 7/19/00 MSDS Identifier: M02-01 Page 1
1. PRODUCT AND MANUFACTURER IDENTIFICATION
This is a biological product with specific
Product Name: Monoclate-P庐 therapeutic activity. It is manufactured and
offered for sale under registration and approval of
Manufacturer: Aventis Behring L.L.C. the U.S. Food and Drug Administration. This
Address: 1020 First Avenue product is not hazardous as classified by OSHA,
PO Box 61501 EPA, or DOT. An MSDS is not required by any
King of Prussia, PA 19406-0901 of these regulatory authorities. Aventis Behring
provides the information as a service to
Telephone Number: (610) 878-4000 customers and others who might handle or
Emergency Telephone Number: (800) 504-5434 otherwise come in contact with this product.
2. COMPOSITION / INFORMATION ON INGREDIENTS
Common Name CAS No. Comments
Antihemophilic Factor VIII:C (Human) NA Active ingredient
Others, when reconstituted to dose-form
Albumin (Human), USP (<2%) NA Stabilizer
Sodium Chloride, USP (<3%) 7647-14-5 Osmotic balance adjustment
Calcium Chloride, USP (<0.5%) 10043-52-4 Osmotic balance adjustment
Mannitol, USP (<1%) 69-65-8 Stabilizer
L-Histidine, USP (<0.5%) 7006-35-1 Stabilizer
Sodium Hydroxide, ACS 1310-73-2 pH adjustment
Hydrochloric Acid, ACS 7647-01-0 pH adjustment
Water For Injection, USP 7732-18-5 Volume adjustment
3. HAZARDS IDENTIFICATION
Potential Health Effects
This product has been prepared from the pooled plasma of healthy adult donors. Each plasma donation has been tested for
the absence of antibodies against HIV-1, HIV-2 and Hepatitis C, as well as for the absence of HIV antigen and Hepatitis B
surface antigens. In addition, the product underwent a minimum of two different virus reduction procedures. However, the
risk of infectivity due to known or as yet unknown pathogens cannot be totally eliminated from this product.
No adverse health effects anticipated with normal handling and use in appropriate medical setting. Medical implications of
therapeutic use are described in product package insert or may be found in the Physicians鈥? Desk Reference.
Emergency Overview:
This product is a sterile prescription pharmaceutical. It is to be administered only at the order of a licensed physician. This
product is safe when used for its intended purpose and administered as directed by a physician. In addition, no adverse
health effects are anticipated as a result of incidental contact or exposure to this product by those handling it or administering
it in a therapeutic setting. More detailed information is available in the product package insert. Please report adverse events
in patients using this product to the manufacturer at the telephone number listed above.
Eye
No data. No adverse health effects reported nor anticipated.
Monoclate-P 庐
Material Safety Data Sheet
Effective Date: 07/20/00 Date Printed: 7/19/00 MSDS Identifier: M02-01 Page 2
Skin Contact
No data. No adverse health effects reported nor anticipated.
Skin Absorption
This product is not absorbed through the skin.
Ingestion
Not intended for oral use. Expected to be relatively non-toxic if ingested.
Chronic Effects/Carcinogenicity
None known or anticipated under normal handling and exposure conditions.
4. FIRST AID MEASURES
Eyes
Flush with water for 15-20 minutes. If irritation develops, seek medical attention.
Skin
Wash with soap and water. If irritation or other symptoms develop, seek medical attention.
Ingestion
Rinse from mouth and seek medical guidance. Induce vomiting only as directed by medical personnel. Never give anything
by mouth to an unconscious person.
Inhalation
If inhaled, remove to fresh air. Seek medical attention if symptoms develop or if breathing is difficult.
5. FIRE FIGHTING MEASURES
FLAMMABLE LIMITS
Flash Pt: NA
Flammable Limits in Air-Lower: NA
Flammable Limits in Air-Upper: NA
Auto-Ignition Temperature: NA
General Hazards
Product is not flammable. The only potential fire hazard would involve packaging material.
Fire Fighting Extinguishing Media
Packaging material fires may be extinguished with water, carbon dioxide, or dry chemical.
Monoclate-P 庐
Material Safety Data Sheet
Effective Date: 07/20/00 Date Printed: 7/19/00 MSDS Identifier: M02-01 Page 3
Fire Fighting Instructions
Fire fighting personnel should respond with appropriate protective clothing, firefighting gear, and breathing equipment as
trained. All other personnel should exit the area and proceed to a gathering point in an area unaffected by the fire and smoke.
Hazardous Combustion Products
Packaging material fire may produce carbon monoxide and other gaseous asphyxiants plus airborne particulate matter.
6. ACCIDENTAL RELEASE MEASURES
Large Spill
Absorb spills with material suitable for aqueous solutions and dispose in solid waste container, or mop spilled material with
detergent/water or bleach/water solution and dispose in sanitary sewer. Ventilate area, if desired.
Small Spill
Clean area of spill with wetted toweling and dispose in solid waste container, or follow procedure for large spills.
7. HANDLING AND STORAGE
Special Handling
Prevent physical damage to package to avoid breakage and spilling.
Special Storage
Store in accordance with the conditions specified in the product package insert.
8. EXPOSURE CONTROLS / PERSONAL PROTECTION
Eye Protection
None required to provide protection against the product. Eye protection may be required by procedure of administration.
Skin Protection
None required to provide protection against the product. Latex gloves may be required by procedure of administration.
Respiratory Protection
None required.
Engineering Controls
Not applicable
Monoclate-P 庐
Material Safety Data Sheet
Effective Date: 07/20/00 Date Printed: 7/19/00 MSDS Identifier: M02-01 Page 4
9. PHYSICAL AND CHEMICAL PROPERTIES
Physical Form of Pure Concentrate Stable, white powder (lyophilized)
As reconstituted:
Physical Form: Clear aqueous solution
Color: None
Odor: Unspecified
Boiling Point: Unspecified
Melting Point: Unspecified
Freezing Point: Unspecified
6.9 卤 0.5
pH:
Solubility in Water: Complete
Specific Gravity: Unspecified
Decomposition Temperature: Unspecified
Odor Threshold: Unspecified
Evaporation Rate: Unspecified
Vapor Pressure: Unspecified
Vapor Density: Unspecified
10. STABILITY AND REACTIVITY
Stability
Stable for period indicated on the label when stored at conditions specified in product package insert.
Incompatibility
No known incompatibilities.
Hazardous Decomposition Products
No known hazardous decomposition products.
Hazardous Polymerization
Hazardous polymerization will not occur.
General Information
No additional information.
11. TOXICOLOGICAL INFORMATION
Toxicology Text
The pure, lyophilized concentrate of Monoclate-P庐 is a sterile, stable white powder with biological activity indicated in the
treatment of Hemophilia A. When reconstituted into its dose-form for intravenous administration, this product is a
pasteurized and sterile, filtered aqueous solution containing human antihemophilic factor VIII:C, stabilizers, and osmotic and
buffering agents. It also contains trace amounts of the monoclonal antibody (a mouse protein) used in the process of
purifying the concentrate. It is not expected to be toxic by ingestion nor a skin/eye irritant. More comprehensive and detailed
product information is contained in the product package insert or may be found in the Physicians鈥? Desk Reference.
Monoclate-P 庐
Material Safety Data Sheet
Effective Date: 07/20/00 Date Printed: 7/19/00 MSDS Identifier: M02-01 Page 5
12. ECOLOGICAL INFORMATION
No ecological damage or persistence in the environment expected under normal conditions of use or with proper disposal.
Environmental fate and transport of this product have not been studied.
13. DISPOSAL CONSIDERATIONS
Disposal Information
Not classified as hazardous waste. Observe all federal, state, and local regulations.
Waste Disposal Methods
Waste must be disposed in accordance with federal, state and local environmental regulations. Uncontaminated product may
be disposed by flushing down the sanitary sewer, or by mixing with a liquid sorbent and then placing mixture in the solid
waste container for disposal. Incineration is the preferred method of disposal for any contaminated product.
14. TRANSPORT INFORMATION
Proper Shipping Name: Not Regulated
Hazard Class: Not Required
Transportation of Hazardous Material Description
Domestic DOT Label: none; International (IMO) label: Drugs/Medicines, ship according to DOT and/or IATA regulations.
15. REGULATORY INFORMATION
TSCA
This material is a biological product regulated by the United States Food and Drug Administration (FDA).
CERCLA
NA
SARA 302
NA
SARA 313
NA
16. OTHER INFORMATION
Prepared By: Aventis Behring Environmental, Health, and Safety Group
Approved By: Vice-President Environmental, Health, and Safety
Approved Date: 07/20/00
Supersedes Date: All prior versions of MSDS
Monoclate-P 庐
Material Safety Data Sheet
Effective Date: 07/20/00 Date Printed: 7/19/00 MSDS Identifier: M02-01 Page 6
Other Information
The information contained herein is based upon data considered true and accurate. Aventis Behring 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. Report to the manufacturer any allegations of health effects resulting from
handling or accidental contact with this material.
Revision Summary
07/20/00 Updated manufacturer identification and transportation labeling information.
05/01/97 Updated format of MSDS, updated hazard and handling information.
05/01/97 Original Aventis Behring MSDS prepared from predecessor MSDS and other product safety information.
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