SDS Number 110563 Approved/Revised 12-May-2008 Version 10
LAMICTAL TABLETS
Material
SAFETY DATA SHEET
* 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
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Material LAMICTAL TABLETS
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LAMICTAL TABLET 25MG * LAMICTAL TABLET 50MG * LAMICTAL TABLET 100MG *
Synonym(s)
LAMICTAL TABLET 150MG * LAMICTAL TABLET 200MG * LAMICTAL VALPROATE
STARTER PACK 25MG * LAMICTAL MONOTHERAPY STARTER PACK 25MG * LAMICTAL
NON-VALPROATE STARTER PACK 50MG * LAMICTAL COMPRIMES * LAMICTAL
COMPRIMIDOS * LAMICTIN TABLETS * NDC NO 0173-0526-00 * NDC NO 0173-0527-00 *
NDC NO 0173-0633-02 * NDC NO 0173-0642-55 * NDC NO 0173-0643-60 * NDC NO
0173-0644-60 * NDC NO 0173-0594-01 * NDC NO 0173-0594-02 * NDC NO 0173-0633-10 *
LAMOTRIGINE, 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.
LAMOTRIGINE 84057-84-1 31 to 50
NON-HAZARDOUS INGREDIENTS Unassigned 50 to 69
3. HAZARDS IDENTIFICATION
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Expected to be non-combustible.
Fire and Explosion
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Caution - Pharmaceutical agent.
Health
Exposure might occur via eyes; skin; ingestion.
May produce allergic skin reactions.
Health effects information is based on hazards of components.
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Harmful to aquatic organisms. May cause long-term adverse effects in the aquatic
Environment
environment.
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SDS Number 110563 Approved/Revised 12-May-2008 Version 10
LAMICTAL TABLETS
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
Medical treatment in cases of overexposure should be treated as an overdose of a sodium
Medical Treatment
channel antagonist. 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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This material may cause or aggravate allergy to phenothiazines.
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.
Special Firefighting
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.
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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.
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SDS Number 110563 Approved/Revised 12-May-2008 Version 10
LAMICTAL TABLETS
Material
8. EXPOSURE CONTROLS / PERSONAL PROTECTION
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LAMOTRIGINE
INGREDIENT
2
GSK Occupational Hazard
Category
GSK Occupational 200 mcg/m3 (8 HR TWA)
Exposure Limit
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PERSONAL PROTECTIVE EQUIPMENT
Wear approved safety glasses with side shields if eye contact is possible.
Eye Protection
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Wear appropriate clothing to avoid skin contact. Wash hands and arms thoroughly after
Other Equipment or
handling.
Procedures
9. PHYSICAL AND CHEMICAL PROPERTIES
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Appearance
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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This preparation contains ingredient(s) with the following activity: a sodium channel
Pharmacological Effects
antagonist.
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Adverse effects might occur in the following organ(s) following overexposure: central nervous
Target Organ Effects
system; red blood cells.
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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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Minor irritation might occur following direct contact with eyes.
Eye Effects
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Allergic skin reactions might occur following repeated contact with this material in susceptible
Sensitisation
individuals.
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Not expected to be genotoxic, based on effects of individual components.
Genetic Toxicity
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No components are listed as carcinogens by GSK, IARC, NTP or US OSHA.
Carcinogenicity
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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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This product contains an active ingredient that has been tested and which may be harmful if
Summary
released directly to the environment. Consult the MSDS of the active ingredient for specific
information about potential environmental effects. Appropriate precautions should be taken to
limit release of this mixture to the environment. Local regulations and procedures should be
consulted prior to environmental release.
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ECOTOXICITY
Aquatic
This material contains an active pharmaceutical ingredient that is not
Activated Sludge
toxic to activated sludge microorganisms.
Respiration
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IC50: > 1000 mg/l, 3 Hours, Activated sludge
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This material contains an active pharmaceutical ingredient that is not
Microbial Growth
toxic to these microorganisms.
Inhibition
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SDS Number 110563 Approved/Revised 12-May-2008 Version 10
LAMICTAL TABLETS
Material
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> 185 mg/l, , Aspergillus flavus
Minimum Inhibition
> 185 mg/l, , Azotobacter chroococcum
Concentration:
> 185 mg/l, , Chaetomium globosum
> 185 mg/l, , Nostoc sp.
> 185 mg/l, , Pseudomonas acidovorans
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This mixture contains an active pharmaceutical ingredient that is
Algal
harmful to algae.
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IC50: 39.7 mg/l, 72 Hours, Selenastrum
capricornutum, green algae, Static test
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NOEC: 7.5 mg/l, 72 Hours, Selenastrum capricornutum,
green algae, Static test
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This mixture contains an active pharmaceutical ingredient that is
Daphnid
harmful to daphnids.
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EC50: 56 mg/l, 48 Hours, Daphnia magna, Static test
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NOEC: 30 mg/l, 48 Hours, Daphnia magna, Static test
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Chronic LOEC: > 10 mg/l, 7 Days, Ceriodaphnia dubia
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Chronic NOEC: 10 mg/l
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This mixture contains an active pharmaceutical ingredient that is
Fish
harmful to fish.
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Adult Oncorhyncus mykiss, rainbow trout
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EC50: 85 mg/l, 96 Hours, Static test
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Adult Oncorhyncus mykiss, rainbow trout
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NOEC: 60 mg/l, 96 Hours, Static test
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MOBILITY
This mixture contains an active pharmaceutical ingredient that for environmental fate
Solubility
predictions has limited solubility in water.
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This mixture contains an active pharmaceutical ingredient that is not likely to adsorb to soil or
Adsorption
sediment if released directly to the environment. This mixture contains an active
pharmaceutical ingredient that is not likely to adsorb to sludge or biomass if released directly
to the environment.
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Sludge Biomass 1.15 Measured at pH 7
Distribution Coefficient
(log Kd):
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This mixture contains an active pharmaceutical ingredient with octanol/water partition
Partitioning
coefficient data that suggests that for environmental fate predictions the active
pharmaceutical ingredient will not have the tendency to distribute into fats.
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PERSISTENCE/DEGRADATION
This material contains an active pharmaceutical ingredient that has been shown to be
Hydrolysis
chemically stable in water. Hydrolysis is unlikely to be a significant depletion mechanism.
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Half-Life, Neutral: > 1 Years, Measured
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This mixture contains an active pharmaceutical ingredient that is likely to undergo
Photolysis
photodegradation.
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UV/Visible Spectrum: 300 nm at pH > 6, Measured
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This mixture contains an active pharmaceutical ingredient that is not readily nor inherently
Biodegradation
biodegradable (as defined by 1993 OECD Testing Guidelines) and may persist in the
environment.
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Aerobic - Ready
Percent Degradation: 0 %, 28 days, Modified Sturm test.
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Aerobic - Inherent
Percent Degradation: 0 %, 14 days, Modified Zahn-Wellens, Activated sludge
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This material contains an active pharmaceutical ingredient that will not have a tendency to
Bioaccumulation
bioaccumulate in the food chain.
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SDS Number 110563 Approved/Revised 12-May-2008 Version 10
LAMICTAL TABLETS
Material
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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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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10
SDS Version Number
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SDS Sections Updated
Sections Subsections
COMPOSITION / INFORMATION ON INGREDIENTS
ECOLOGICAL INFORMATION
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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