Material Safety Data Sheet
Nabi Biopharmaceuticals Emergency Telephone Number
5800 Park of Commerce Blvd, N.W. (352) 323-3500 (InfoTrac)
Boca Raton, FL 33487
Telephone Number for Information
(561) 989-5800
MSDS Prepared: June 15, 2005
SECTION 1 - SUBSTANCE IDENTITY
Product Name: Hepatitis B Immune Globulin (Human)
Synonyms: Nabi-HB?br>
SECTION 2 - CHEMICAL COMPOSITION AND DATA ON COMPONENTS
Components OSHA PEL ACGIH TLV CAS Number
Human Immunoglobulin N/A N/A N/A
Glycine N/A N/A 56-40-6
Sodium Chloride N/A N/A 7647-14-5
Polysorbate 80 N/A N/A 9005-65-6
Sterile Water N/A N/A 7732-18-5
SECTION 3 - HAZARDS IDENTIFICATION
Hepatitis B Immune Globulin (Human), Nabi-HB? is a sterile solution of immunoglobulin
containing antibodies to hepatitis B surface antigen (anti-HBs). Considered a biological
product, Nabi-HB?is prepared from plasma donated by individuals with high titers of
anti-HBs and is manufactured and distributed in accordance with the requirements of the
United States Food and Drug Administration.
Biological products may contain infectious agents, such as viruses, that can cause
disease. However, screening plasma donors for prior exposure to certain viruses and
testing for the presence of certain viral infections has reduced the risk that this will occur.
In addition, the manufacturing steps for Nabi-HB?are designed to reduce the risk of
transmission of viral disease. Despite these measures, this biological product can still
potentially transmit disease. There is also the possibility that unknown infectious agents
may be present. As with any biological product, this product also has the potential for
causing rare allergic or anaphylactic reactions.
This material contains no carcinogens or potential carcinogens (as identified by IARC,
NTP or OSHA) at 0.1% or greater concentration. This product is a "mixture" of USP and
NF chemicals and purified water for which no health hazard data exists. This mixture is
not known to present a health hazard.
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SECTION 4 - FIRST AID MEASURES
Ingestion: Seek medical consultation immediately.
Medical consultant should be familiar with
OSHA Bloodborne Pathogen Standard (29
CFR 1910.1030) and the current U.S. Public
Health Service/CDC guidelines.
Inhalation (i.e. aerosols): Seek medical consultation immediately.
Medical consultant should be familiar with
OSHA Bloodborne Pathogen Standard (29
CFR 1910.1030) and the current U.S. Public
Health Service/CDC guidelines.
Intact Skin Contact: Wash area well with soap and water. In the
unlikely event that irritation persists, seek
medical care.
Mucous Membrane/Percutaneous: Flush area with water for 15 minutes. Seek
(i.e. splashes to eyes, nose, mouth medical consultation immediately. Medical
and/or needlesticks, cuts to skin) consultant should be familiar with the OSHA
Bloodborne Pathogens Standard (29 CFR
1910.1030) and the current U.S. Public
Health Service/CDC guidelines.
Note to Physician: N/A
SECTION 5 ?FIRE AND EXPLOSION DATA
Fire: Not considered to be a fire hazard.
Explosion: Not considered to be an explosion hazard.
Fire Extinguishing Media: Noncombustible. Use extinguishing media
appropriate to surrounding fire conditions.
Special Fire Fighting Procedures: Use protective clothing and breathing
equipment appropriate for the surrounding
fire.
SECTION 6 - ACCIDENTAL RELEASE MEASURES
Solutions of spilled materials can be taken up with absorbent material. Wear gloves and
eye protection. Dispose of in accordance with local, state and federal regulations.
SECTION 7 - HANDLING AND STORAGE
Store in original container in cool dry area between 2 - 8癈. Protect from physical
damage.
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SECTION 8 - EXPOSURE CONTROLS AND PERSONAL PROTECTION
Utilize gloves and eye protection. Do not mouth pipette. Care must be taken when
handling material in hypodermic syringes.
SECTION 9 - PHYSICAL AND CHEMICAL PROPERTIES
Solubility in Water: Complete
Specific Gravity: N/A
Freezing Point: N/A
Boiling Point: N/A
Vapor Pressure: N/A
Melting Point: N/A
Vapor Density: N/A
Evaporation Rate: N/A
Odor: Odorless
pH: 5.8 - 6.5
Appearance: Clear to opalescent liquid
SECTION 10 - STABILITY AND REACTIVITY
Stability: Stable
Conditions to Avoid: None known
Incompatibility (Materials to Avoid): Strong oxidizing agents (sodium hypochlorite,
hypochlorous acid, nitric acid)
Hazardous Decomposition Byproducts: Glycine and Polysorbate 80 may decompose
to carbon dioxide and carbon monoxide when
heated to decomposition. Glycine may
produce nitrogen oxides. When heated to
above 804癈 sodium chloride emits toxic
vapors of chloride and sodium oxide.
Hazardous Polymerization: None known
SECTION 11 - TOXICOLOGICAL INFORMATION
None
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SECTION 12 - ECOLOGICAL INFORMATION
None
SECTION 13 - DISPOSAL CONSIDERATIONS
Dispose of in accordance with local, state and federal regulations.
SECTION 14 - TRANSPORT INFORMATION
According to DOT and IATA regulations this material is considered a biological product
and should be shipped accordingly.
SECTION 15 ?REGULATORY INFORMATION
The Food and Drug Administration has licensed this product.
SECTION 16 - OTHER INFORMATION
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Nabi Biopharmaceuticals provides the information contained herein in good faith but
makes no representation as to its comprehensiveness or accuracy. This document is
intended only as a guide to the appropriate precautionary handling of the product by
properly trained personnel. Individuals receiving this information must exercise their
independent judgment in determining its appropriateness for a particular purpose. NABI
BIOPHARMACEUTICALS MAKES NO REPRESENTATIONS OR WARRANTIES,
EITHER EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY
WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE, WITH RESPECT TO THE INFORMATION SET FORTH HEREIN.
ACCORDINGLY, NABI BIOPHARMACEUTICALS WILL NOT BE RESPONSIBLE FOR
DAMAGES RESULTING FROM USE OF OR RELIANCE UPON THIS INFORMATION.
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