SDS Number 130346 Approved/Revised 10-Apr-2008 Version 7
FLULAVAL
Material
SAFETY DATA SHEET
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
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Material FLULAVAL
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FLULAVAL (INFLUENZA VIRUS VACCINE) INTRAMUSCULAR INJECTION * VACCIN
Synonym(s)
FLUVIRAL * GRIPLAVAL * NDC 19515-884-07 * NDC 19515-885-07 * INFLUENZA VIRUS
VACCINE, TRIVALENT, INACTIVATED
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GlaxoSmithKline, Corporate Environment, Health & Safety
Company Name
980 Great West Road
Brentford, Middlesex TW8 9GS UK
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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
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GlaxoSmithKline, Corporate Environment, Health & Safety
One Franklin Plaza, 200 N 16th Street
Philadelphia, PA 19102-1225 US
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US General Information: +1-888-825-5249
Transport Emergency (non EU) +1-703-527-3887
US number, available 24 hours
Multi-language response
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2. COMPOSITION / INFORMATION ON INGREDIENTS
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Ingredients CAS # Percent EC-No.
ETHYLMERCURITHIOSALICYLIC ACID 54-64-8 0.01
SODIUM SALT
MONOVALENT SPLIT-VIRION DRUG 0.002
SUBSTANCE, A/H1N1
MONOVALENT SPLIT-VIRION DRUG 0.002
SUBSTANCE, A/H3N2
MONOVALENT SPLIT-VIRION DRUG 0.002
SUBSTANCE, B STRAIN
Other components below reportable levels >99
3. HAZARDS IDENTIFICATION
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This product is classified as non-flammable.
Fire and Explosion
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Handling this product in its final form presents minimal risk from occupational exposure.
Health
Health effects information is based on hazards of components.
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No information is available about the potential of this product to produce adverse
Environment
environmental effects.
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SDS Number 130346 Approved/Revised 10-Apr-2008 Version 7
FLULAVAL
Material
4. FIRST-AID MEASURES
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Never attempt to induce vomiting. Do not attempt to give any solid or liquid by mouth if the
Ingestion
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.
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Physical form suggests that risk of inhalation exposure is negligible.
Inhalation
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Using appropriate personal protective equipment, remove contaminated clothing and flush
Skin Contact
exposed area with large amounts of water. Obtain medical attention if skin reaction occurs,
which may be immediate or delayed.
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Wash immediately with clean and gently flowing water. Continue for at least 15 minutes.
Eye Contact
Obtain medical attention.
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NOTES TO HEALTH PROFESSIONALS
None.
Medical Treatment
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The components contained in this vaccine are generally not considered to cause disease in
Medical Conditions
humans.
Caused or Aggravated by
Exposure
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No specific antidotes are recommended.
Antidotes
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5. FIRE-FIGHTING MEASURES
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Not expected for the product, although the packaging is combustible.
Fire and Explosion Hazards
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Water is recommended for fires involving packaging.
Extinguishing Media
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For single units (packages): No special requirements needed. For larger amounts (multiple
Special Firefighting
packages/pallets) of product: Since toxic, corrosive or flammable vapours might be evolved
Procedures
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.
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Toxic, corrosive or flammable thermal decomposition products are expected when the
Hazardous Combustion
product is exposed to fire.
Products
6. ACCIDENTAL RELEASE MEASURES
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Wear protective clothing and equipment consistent with the degree of hazard.
Personal Precautions
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For large spills, take precautions to prevent entry into waterways, sewers, or surface drainage
Environmental Precautions
systems.
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Collect and place it in a suitable, properly labelled container for recovery or disposal.
Clean-up Methods
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Water can be used for clean-up and decontamination operations. Sodium hypochlorite
Decontamination Procedures
(bleach) or other strong oxidizers can be used in clean-up decontamination operations.
Contaminated surfaces should be washed with water, then bleach or other oxidizing solution,
followed by another water wash.
7. HANDLING AND STORAGE
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HANDLING
No special control measures required for the normal handling of this product. Normal room
General Requirements
ventilation is expected to be adequate for routine handling of this product.
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No storage requirements are considered necessary for the control of fire and explosion
STORAGE
hazards.
DO NOT FREEZE. Dispose of properly if frozen.
8. EXPOSURE CONTROLS / PERSONAL PROTECTION
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None required for normal handling. Wash hands and arms thoroughly after handling.
Other Equipment or
Procedures
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SDS Number 130346 Approved/Revised 10-Apr-2008 Version 7
FLULAVAL
Material
9. PHYSICAL AND CHEMICAL PROPERTIES
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Appearance
Clear to opalescent.
Clarity
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Colourless.
Colour
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Liquid.
Physical Form
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7.1
pH of Aqueous Solutions
10. STABILITY AND REACTIVITY
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DO NOT FREEZE - dispose of properly if frozen.
Stability
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None for normal handling of this product.
Conditions to Avoid
11. TOXICOLOGY INFORMATION
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Routes of Exposure
Not expected to be toxic following ingestion.
Oral Toxicity
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Irritation is not expected following direct contact.
Skin Effects
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Irritation is not expected following direct contact with eyes.
Eye Effects
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Sensitisation (allergic skin reaction) is not expected.
Sensitisation
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Not expected to be genotoxic under occupational exposure conditions.
Genetic Toxicity
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No components are listed as carcinogens by GSK, IARC, NTP or US OSHA. Not expected to
Carcinogenicity
produce cancer in humans under occupational exposure conditions.
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Not expected to produce adverse effects on fertility or development under occupational
Reproductive Effects
exposure conditions.
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None known for occupational exposure.
Other Adverse Effects
12. ECOLOGICAL INFORMATION
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No information is available about the potential of this product to produce adverse
Summary
environmental effects. Local regulations and procedures should be consulted prior to
environmental release.
13. DISPOSAL CONSIDERATIONS
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The disposal method for rejected products/returned goods must ensure that they cannot be
Disposal Recommendations
re-sold or re-used.
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Observe all local and national regulations when disposing of this product.
Regulatory Requirements
14. TRANSPORT INFORMATION
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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.
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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
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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.
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EU Classification and Labelling
Exempt from requirements of EU Dangerous Preparations directive - product regulated as a medicinal product,
cosmetic product or medical device.
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SDS Number 130346 Approved/Revised 10-Apr-2008 Version 7
FLULAVAL
Material
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US OSHA Standard (29 CFR Part 1910.1200)
This product is exempt from the requirements of the OSHA Hazard Communication
Classification
Standard.
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Other US Regulations
Exempt
TSCA Status
16. OTHER INFORMATION
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GSK Hazard Determination
References
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7
SDS Version Number
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SDS Sections Updated
Sections Subsections
COMPOSITION / INFORMATION ON INGREDIENTS
IDENTIFICATION OF SUBSTANCE / PREPARATION AND OF
COMPANY
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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.
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