MATERIAL SAFETY DATA SHEET
1 IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
Material COMBINED HEPATITIS A/HEPATITIS B VACCINE
HAB VACCINE * TWINRIX * TWINRIX ADULT * NDC NO.
Tradenames/Synonyms
58160-850-01 * NDC NO. 58160-850-11 * NDC NO. 58160-850-31 *
NDC NO. 58160-850-35 * NDC NO. 58160-850-41 * NDC NO.
58160-850-46
GlaxoSmithKline, Environment Health & Safety
Company Name
2200 Renaissance Blvd. Suite 105
King of Prussia, PA 19406 USA
General Information +1 610-239-5229
24-Hour Medical Emergency +1-800-228-5635, Ext. 221
Outside North America +1-612-221-3999, Ext. 221
24-Hour Transport Emergency +1-800-424-9300
Outside North America +1-703-527-3887
2 COMPOSITION / INFORMATION ON INGREDIENTS
Percentage
Ingredients CAS RN
HEPATITIS A VIRUS INACTIVATED Not applicable
Unassigned
HEPATITIS B VIRUS SURFACE ANTIGEN Not applicable
Unassigned
NON-HAZARDOUS INGREDIENTS > 99
Unassigned
3 HAZARDS IDENTIFICATION
HEALTH HAZARDS
Skin Contact Not expected to occur during normal handling. Allergic reaction and irritation
are not expected following direct contact.
Eye Contact Not expected to occur during normal handling of this product. Minor irritation
with redness or swelling might occur following direct contact.
Inhalation Inhalation should not occur with normal use of this material. Repeated
breathing might produce an allergic reaction including rhinitis, sneezing,
itching or signs similar to asthma such as coughing, wheezing or difficulty
breathing.
Ingestion Toxicity following ingestion is not expected.
Conditions Aggravated Allergy to components in this vaccine.
by Exposure
ENVIRONMENTAL HAZARDS
Summary No information is available about the potential of this material to produce
adverse environmental effects. Local regulations and procedures should be
consulted prior to environmental release.
4 FIRST-AID MEASURES
Skin Contact In the event of occupational skin contact, wash contaminated area
thoroughly.
Eye Contact Flush eyes continuously with water for at least 15 minutes. Do not use a
chemical neutraliser. Obtain medical assistance if symptoms occur.
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Material COMBINED HEPATITIS A/HEPATITIS B VACCINE
Inhalation Not applicable for this product.
Ingestion In the event of occupational ingestion, seek medical advice. Induction of
vomiting is not a recommended first-aid procedure.
Notes to Physician The components contained in this vaccine are generally not considered to
cause disease in humans.
Antidotes No specific antidotes known.
5 FIRE-FIGHTING MEASURES
Fire and Explosion Not expected for the product, although the packaging is combustible.
Hazards
Fire Control The contents of the vial are not expected to support combustion. Toxic or
corrosive gases are expected if this material is exposed to fire.
Special Firefighting No special firefighting requirements. Where appropriate, collect product or
Procedures firefighting water for later disposal.
Hazardous Decomposition None for normal handling of this material.
Products
6 ACCIDENTAL RELEASE MEASURES
Spills No special requirements for spills from single containers. For large spills,
take precautions to prevent entry into waterways, sewers, or surface
drainage systems. Use protective clothing during clean-up prior to disposal
of spilled material.
Decontamination Water can be used to clean up spills. Decontamination with a solution such
Procedures as 200 ppm sodium hypochlorite, or bleach, is recommended.
7 HANDLING AND STORAGE
Handling No special control measures required for the normal handling of this
material. Normal room ventilation is expected to be adequate for routine
handling of this material.
Storage No storage requirements necessary for occupational hazards. This vaccine
should be stored in a refrigerator between 2 to 8 degrees C (36 to 46
degrees F).
DO NOT FREEZE. Dispose of properly if frozen.
8 EXPOSURE CONTROLS/PERSONAL PROTECTION
PERSONAL PROTECTIVE EQUIPMENT
Other Equipment or Wash hands and arms thoroughly after handling. None required for normal
Procedures handling.
9 PHYSICAL AND CHEMICAL PROPERTIES
Appearance
Clarity Cloudy.
Colour White.
Physical Form Suspension which might separate.
10 STABILITY AND REACTIVITY
Conditions to Avoid None for normal handling of this material.
Stability DO NOT FREEZE. Dispose of properly if frozen.
11 TOXICOLOGICAL INFORMATION
Oral Toxicity The oral LD50 is expected to be greater than 2000 mg/kg in rats, based on
calculations relating to the effects of individual components and
concentrations present.
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Material COMBINED HEPATITIS A/HEPATITIS B VACCINE
Inhalation Toxicity Respiratory sensitisation might occur based on effects of individual
components.
Skin Toxicity Irritation is not expected based on effects of individual components.
Eye Effects Irritation might occur based on effects of individual components.
Sensitisation Allergic reactions can occur, based on effects of similar substances.
Genetic Toxicity Not expected to be genotoxic, based on effects of individual components.
Carcinogenicity No components are listed as carcinogens by GSK, IARC, NTP or US
OSHA.
12 ECOLOGICAL INFORMATION
Summary No information is available about the potential of this material to produce
adverse environmental effects. Local regulations and procedures should be
consulted prior to environmental release.
13 DISPOSAL CONSIDERATIONS
Disposal The disposal method for rejected products/returned goods must ensure that
Recommendations they cannot be re-sold or re-used.
SB Standards and SB E-7 and G-E-7.
Guidance
Regulatory Requirements Consult local regulations prior to disposal.
14 TRANSPORT INFORMATION
The MSDS should accompany all shipments for reference in the event of spillage or accidental release.
Transportation and shipping of this material is not restricted. It has no known,
Classification and
significant hazards requiring special packaging or labelling for air, maritime,
Labelling
US or European ground transport purposes.
15 REGULATORY INFORMATION
No European Union labelling requirements.
European Union
Classification and Labelling
US Environmental (EPA) No US EPA reporting requirements.
Requirements
US OSHA Labeling No specific OSHA labeling requirements.
Requirements
16 OTHER INFORMATION
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Material COMBINED HEPATITIS A/HEPATITIS B VACCINE
INFORMATION ON HAZARD LABELLING:
COMBINED HEPATITIS A/HEPATITIS B VACCINE
This product is exempt from hazard labelling requirements since it is
regulated either as a medicine or cosmetic product.
References SB HAZARD DETERMINATION
The information contained herein is based on data considered accurate. However, no warranty is expressed
or implied regarding the accuracy of these data or the results to be obtained from the use thereof. The
publisher, its parent, subsidiaries and affiliates assume no responsibility for personal injury or property
damage to vendees, users or third parties caused by the material. Such persons assume all risks associated
with the use of the material.
Date Approved/Revised 06-Jul-2001 Version Number 10
MSDS Sections Updated
Sections Subsections
HAZARDS IDENTIFICATION Skin Contact
IDENTIFICATION OF SUBSTANCE / PREPARATION AND
OF COMPANY INFORMATION
TOXICOLOGY Carcinogenicity
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Material COMBINED HEPATITIS A/HEPATITIS B VACCINE
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