SDS Number 110481 Approved/Revised 30-Mar-2007 Version 17
ENGERIX-B PRESERVATIVE FREE
Material
SAFETY DATA SHEET
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
Material ENGERIX-B PRESERVATIVE FREE
ENGERIX-B ADOLESCENT PRESERVATIVE FREE * ENGERIX-B
Synonyms
PAEDIATRIC PRESERVATIVE FREE * ENGERIX-B INFANT PRESERVATIVE
FREE * ENGERIX-B PRESERVATIVE FREE 10 MCG/0.5 ML * ENGERIX-B
PRESERVATIVE FREE 20 MCG/1 ML * ENGERIX-B ERWACHSENE
AMPULLE MIT 1 ML SUSPENSION * ENGERIX-B ERWACHSENE
FERTIGSPRITZE MIT 1 ML SUSPENSION * ENGERIX-B KINDER
FERTIGSPRITZE MIT 0.5 ML SUSPENSION * NDC NO. 58160-820-11 * NDC
NO. 58160-820-46 * NDC NO. 58160-821-11 * NDC NO. 58160-821-46 *
HEPATITIS B SURFACE ANTIGEN VACCINE * HEPATITIS B
(RECOMBINANT DNA) VACCINE (ADSORBED)
GlaxoSmithKline, Corporate Environment, Health & Safety
Company Name
980 Great West Road
Brentford, Middlesex TW8 9GS UK
UK General Information: +44-20-8047-5000
Transport Emergency (EU) +44-1865-407333
Medical Emergency +1-612-221-3999, Ext 221
Information and Advice: US number, available 24 hours
Multi-language response
GlaxoSmithKline, Corporate Environment, Health & Safety
One Franklin Plaza, 200 N 16th Street
Philadelphia, PA 19102-1225 US
US General Information: +1-888-825-5249
Transport Emergency (non EU) +1-703-527-3887
US number, available 24 hours
Multi-language response
2. COMPOSITION / INFORMATION ON INGREDIENTS
Percentage
Ingredients CAS RN
HEPATITIS B VIRUS SURFACE ANTIGEN Not applicable
Unassigned
NON-HAZARDOUS INGREDIENTS >99
Unassigned
3. HAZARDS IDENTIFICATION
This product is classified as non-flammable.
Fire and Explosion
Page 1 / 4
SDS Number 110481 Approved/Revised 30-Mar-2007 Version 17
ENGERIX-B PRESERVATIVE FREE
Material
Health Handling this product in its final form presents minimal risk from
occupational exposure.
May produce allergic skin reactions. Possible effects of overexposure in the
workplace include: symptoms of hypersensitivity (such as skin rash, hives,
itching, and difficulty breathing). Health effects information is based on
hazards of components.
Environment No information is available about the potential of this product to produce
adverse environmental effects.
4. FIRST-AID MEASURES
Ingestion Never attempt to induce vomiting. Do not attempt to give any solid or liquid
by mouth if the exposed subject is unconscious or semi-conscious. Wash
out the mouth with water. If the exposed subject is fully conscious, give
plenty of water to drink. Obtain medical attention.
Inhalation Physical form suggests that risk of inhalation exposure is negligible.
Skin Contact Using appropriate personal protective equipment, remove contaminated
clothing and flush exposed area with large amounts of water. Obtain
medical attention if skin reaction occurs, which may be immediate or
delayed.
Eye Contact Wash immediately with clean and gently flowing water. Continue for at least
15 minutes. Obtain medical attention.
NOTES TO HEALTH PROFESSIONALS
Medical Treatment None.
Medical Conditions The components contained in this vaccine are generally not considered to
cause disease in humans.
Caused or Aggravated
by Exposure
Antidotes No specific antidotes are recommended.
5. FIRE-FIGHTING MEASURES
Fire and Explosion Not expected for the product, although the packaging is combustible.
Hazards
Extinguishing Media Water is recommended for fires involving packaging.
Special Firefighting For single units (packages): No special requirements needed. For larger
amounts (multiple packages/pallets) of product: Since toxic, corrosive or
Procedures
flammable vapours might be evolved from fires involving this product and
associated packaging, self contained breathing apparatus and full protective
equipment are recommended for firefighters. If possible, contain and collect
firefighting water for later disposal.
Hazardous Combustion Toxic, corrosive or flammable thermal decomposition products are
expected when the product is exposed to fire.
Products
6. ACCIDENTAL RELEASE MEASURES
Personal Precautions Wear protective clothing and equipment consistent with the degree of
hazard.
Environmental Precautions For large spills, take precautions to prevent entry into waterways, sewers, or
surface drainage systems.
Clean-up Methods Collect and place it in a suitable, properly labelled container for recovery or
disposal.
Page 2 / 4
SDS Number 110481 Approved/Revised 30-Mar-2007 Version 17
ENGERIX-B PRESERVATIVE FREE
Material
Decontamination Water can be used for clean-up and decontamination operations. Sodium
hypochlorite (bleach) or other strong oxidizers can be used in clean-up
Procedures
decontamination operations. Contaminated surfaces should be washed with
water, then bleach or other oxidizing solution, followed by another water
wash.
7. HANDLING AND STORAGE
HANDLING
General Requirements No special control measures required for the normal handling of this
product. Normal room ventilation is expected to be adequate for routine
handling of this product.
STORAGE DO NOT FREEZE. Dispose of properly if frozen.
8. EXPOSURE CONTROLS/PERSONAL PROTECTION
Other Equipment or None required for normal handling. Wash hands and arms thoroughly after
handling.
Procedures
9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance
Liquid suspension.
Physical Form
10. STABILITY AND REACTIVITY
Stability DO NOT FREEZE - dispose of properly if frozen.
Conditions to Avoid None for normal handling of this product.
11. TOXICOLOGICAL INFORMATION
Oral Toxicity Not expected to be toxic following ingestion.
Inhalation Toxicity No studies have been conducted.
Skin Effects Irritation is not expected following direct contact.
Eye Effects Irritation is not expected following direct contact with eyes.
Sensitisation Allergic skin reactions might occur following dermal exposure. Assessment
based upon effects of structurally similar substances. Respiratory
sensitisation (allergic) reactions might occur following exposure.
Genetic Toxicity Not expected to be genotoxic under occupational exposure conditions.
Carcinogenicity Not expected to produce cancer in humans under occupational exposure
conditions. No components are listed as carcinogens by GSK, IARC, NTP
or US OSHA.
Reproductive Effects Not expected to produce adverse effects on fertility or development under
occupational exposure conditions.
Other Adverse Effects None known for occupational exposure.
12. ECOLOGICAL INFORMATION
Summary No information is available about the potential of this product 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
they cannot be re-sold or re-used.
Recommendations
Page 3 / 4
SDS Number 110481 Approved/Revised 30-Mar-2007 Version 17
ENGERIX-B PRESERVATIVE FREE
Material
Regulatory Requirements Observe all local and national regulations when disposing of this product.
14. TRANSPORT INFORMATION
The SDS should accompany all shipments for reference in the event of spillage or accidental release. Only
authorised persons trained and competent in accordance with appropriate national and international
regulatory requirements may prepare dangerous goods for transport.
UN Classification and Labelling
Transportation and shipping of this product is not restricted. It has no known,
Transport Information
significant hazards requiring special packaging or labelling for air, maritime, US
or European ground transport purposes.
15. REGULATORY INFORMATION
The information included below is an overview of the major regulatory requirements. It should not be
considered to be an exhaustive summary. Local regulations should be consulted for additional requirements.
EU Classification and Labelling
Exempt from requirements of EU Dangerous Preparations directive - product regulated as a medicinal
product, cosmetic product or medical device.
US OSHA Standard (29 CFR Part 1910.1200)
Classification This product is exempt from the requirements of the OSHA Hazard
Communication Standard.
Other US Regulations
TSCA Status Exempt
16. OTHER INFORMATION
References GSK Hazard Determination
Date Approved/Revised 30-Mar-2007 SDS Version Number 17
SDS Sections Updated
Sections Subsections
IDENTIFICATION OF SUBSTANCE / PREPARATION AND
OF COMPANY
The information and recommendations in this safety data sheet are, to the best of our knowledge, accurate
as of the date of issue. Nothing herein shall be deemed to create any warranty, express or implied. It is the
responsibility of the user to determine the applicability of this information and the suitability of the material
or product for any particular purpose.
Page 4 / 4
|