SDS Number 4365 Approved/Revised 09-Jul-2008 Version 13
LISKONUM TABLETS
Material
SAFETY DATA SHEET
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
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Material LISKONUM TABLETS
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LISKONUM CONTROLLED RELEASE TABLETS 450 MG * ESKALITH CONTROLLED
Synonym(s)
RELEASE TABLETS 450 MG * QUILONUM SR TABLETS * QUILONUM 450 MG SR
TABLETS * QUILONIUM-R TABLETS * LITHIUM CARBONATE, FORMULATED PRODUCT
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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.
LITHIUM CARBONATE 554-13-2 64
Other components below reportable levels 36
3. HAZARDS IDENTIFICATION
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Expected to be non-combustible.
Fire and Explosion
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Exposure might occur via ingestion; skin; eyes.
Health
Caution - Pharmaceutical agent.
Eye irritant.
May produce adverse effects on the development of human offspring.
Possible effects of overexposure in the workplace include: drowsiness; weakness; changes in
mood.
Health effects information is based on hazards of components.
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Dangerous for the environment. Toxic to aquatic organisms.
Environment
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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SDS Number 4365 Approved/Revised 09-Jul-2008 Version 13
LISKONUM TABLETS
Material
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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
Medical treatment in cases of overexposure should be treated as an overdose of lithium .
Medical Treatment
Treat according to locally accepted protocols. For additional guidance, refer to the current
prescribing information or to the local poison control information centre.
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None for occupational exposure.
Medical Conditions
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, dry powder or foam extinguishers are recommended. Carbon dioxide extinguishers
Extinguishing Media
may be ineffective.
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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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No specific decontamination or detoxification procedures have been identified for this
Decontamination Procedures
product.
7. HANDLING AND STORAGE
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HANDLING
Avoid breaking or crushing tablets.
General Requirements
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No storage requirements necessary for occupational hazards. Follow product information
STORAGE
storage instructions to maintain efficacy.
8. EXPOSURE CONTROLS / PERSONAL PROTECTION
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LITHIUM CARBONATE
INGREDIENT
2
GSK Occupational Hazard
Category
REPRODUCTIVE HAZARD
GSK Occupational 400 MCG/M3 (8 HR TWA)
Exposure Limit
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PERSONAL PROTECTIVE EQUIPMENT
Wear approved safety glasses with side shields or cover goggles if eye contact is possible.
Eye Protection
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Wash hands and arms thoroughly after handling.
Other Equipment or
Procedures
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SDS Number 4365 Approved/Revised 09-Jul-2008 Version 13
LISKONUM TABLETS
Material
9. PHYSICAL AND CHEMICAL PROPERTIES
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Appearance
White.
Colour
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Film-coated tablet.
Physical Form
10. STABILITY AND REACTIVITY
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This product is expected to be stable.
Stability
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None for normal handling of this product.
Conditions to Avoid
11. TOXICOLOGY INFORMATION
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Adverse effects might occur in the following organ(s) following overexposure: central nervous
Target Organ Effects
system.
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Routes of Exposure
Adverse effects might occur following ingestion.
Oral Toxicity
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No studies have been conducted.
Inhalation Toxicity
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Irritation is not expected following direct contact.
Skin Effects
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Irritation might occur 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.
Carcinogenicity
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Contains components which have been classified as: Known or presumed to cause toxicity in
Reproductive Effects
developing human offspring. Known or presumed to affect the quantity and quality of breast
milk in humans.
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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 material to produce adverse
Summary
environmental effects. Local regulations and procedures should be consulted prior to
environmental release.
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ECOTOXICITY
Aquatic
This mixture contains an active pharmaceutical ingredient that is toxic
Daphnid
to daphnids.
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This mixture contains an active pharmaceutical ingredient that is toxic
Fish
to fish.
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MOBILITY
This mixture contains an active pharmaceutical ingredient that for environmental fate
Solubility
predictions has solubility in water.
13. DISPOSAL CONSIDERATIONS
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Collect for recycling or recovery if possible. The disposal method for rejected
Disposal Recommendations
products/returned goods must ensure that they cannot be 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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SDS Number 4365 Approved/Revised 09-Jul-2008 Version 13
LISKONUM TABLETS
Material
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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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US OSHA Standard (29 CFR Part 1910.1200)
This dosage form 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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13
SDS Version Number
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SDS Sections Updated
Sections Subsections
COMPOSITION / INFORMATION ON INGREDIENTS
ECOLOGICAL INFORMATION
HAZARDS IDENTIFICATION Health
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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