SDS Number 4172 Approved/Revised 21-Aug-2003 Version 08
MENCEVAX AC MONODOSE
Material
SAFETY DATA SHEET
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
Material MENCEVAX AC MONODOSE
AC VAX, MENINGOCOCCAL POLYSACCHARIDE VACCINE * MENCEVAX
Synonyms
AC FLACON MONODOSE * MENCEVAX AC FRASCO AMPOLLA *
MENCEVAX AC INJECTION * MENCEVAX AC INJECTABLE * MENCEVAX
AC VIAL * MENCEVAX AC INJEKSJONSSUBSTANS * MENCEVAX AC VIAL
LIOFILIZADO * MENCEVAX-AC VIAL
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
2200 Renaissance Blvd, Suite 105
King of Prussia, PA 19406 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
PURIFIED POLYSACCHARIDE GROUP A NEISSERIA MENINGITIDIS Not applicable
Unassigned
PURIFIED POLYSACCHARIDE GROUP C NEISSERIA MENINGITIDIS Not applicable
Unassigned
NON-HAZARDOUS INGREDIENTS <100
Unassigned
3. HAZARDS IDENTIFICATION
This product is expected to be non-combustible.
Fire and Explosion
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.
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SDS Number 4172 Approved/Revised 21-Aug-2003 Version 08
MENCEVAX AC MONODOSE
Material
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 Prevent entry into waterways, sewers, surface drainage systems and poorly
ventilated areas.
Clean-up Methods Spread an inert absorbent on the spill and place in a suitable, properly
labelled container for recovery or disposal.
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
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SDS Number 4172 Approved/Revised 21-Aug-2003 Version 08
MENCEVAX AC MONODOSE
Material
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 The recommended temperature for storage is 2-8 掳C. Keep away from light.
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
White.
Colour
Lyophilised pellet.
Physical Form
Vial.
Packaging
10. STABILITY AND REACTIVITY
Stability This product is expected to be stable.
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.
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
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.
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SDS Number 4172 Approved/Revised 21-Aug-2003 Version 08
MENCEVAX AC MONODOSE
Material
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
None.
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 21-Aug-2003 SDS Version Number 8
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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