SDS Number 110551 Approved/Revised 03-Jul-2008 Version 11
EPIVIR TABLETS 150 MG
Material
SAFETY DATA SHEET
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
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Material EPIVIR TABLETS 150 MG
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EPIVIR 3TC TABLETS * EPIVIR APVALKOTAS TABLETES * EPIVIR COMPRESSE *
Synonym(s)
EPIVIR COMPRIME PELLICULE * EPIVIR COMPRIMES * EPIVIR COMPRIMIDOS * EPIVIR
COMPRIMIDOS REVESTIDOS * EPIVIR FILM TABLET * EPIVIR FILMOM OBALENE
TABLETY * EPIVIR FILMOVERTRUKNE TABLETTER * EPIVIR FILMTABLETTEN * EPIVIR
POTAHOVANE * EPIVIR TABLETAS * EPIVIR TABLETE * EPIVIR TABLETES * EPIVIR
TABLETTEN * EPIVIR TABLETTER * EPIVIR TABLETTI * 3TC TABLETS 150 MG * NDC NO
0173-0470-01 * LAMIVUDINE, 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
.
2. COMPOSITION / INFORMATION ON INGREDIENTS
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Ingredients CAS # Percent EC-No.
LAMIVUDINE 134678-17-4 44
NON-HAZARDOUS INGREDIENTS Unassigned 56
3. HAZARDS IDENTIFICATION
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Expected to be non-combustible.
Fire and Explosion
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Caution - Pharmaceutical agent.
Health
May produce adverse effects on the development of human offspring.
Possible effects of overexposure in the workplace include: abdominal pain; headache;
nausea; vomiting; fatigue; rash.
Exposure might occur via ingestion; skin; eyes.
Health effects information is based on hazards of components.
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No environmental hazards have been identified for this material.
Environment
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SDS Number 110551 Approved/Revised 03-Jul-2008 Version 11
EPIVIR TABLETS 150 MG
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 an anti-viral
Medical Treatment
agent. Treat according to locally accepted protocols. For additional guidance, refer to the
local poison control information centre.
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Refer to prescribing information for detailed description of medical conditions caused by or
Medical Conditions
aggravated by overexposure to this product.
Caused or Aggravated by
Exposure
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Pre-placement and periodic health surveillance is not usually indicated. The final
Health Surveillance
determination of the need for health surveillance should be determined by local risk
Procedures
assessment.
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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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Water can be used for clean-up and decontamination operations.
Decontamination Procedures
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 110551 Approved/Revised 03-Jul-2008 Version 11
EPIVIR TABLETS 150 MG
Material
8. EXPOSURE CONTROLS / PERSONAL PROTECTION
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LAMIVUDINE
INGREDIENT
2
GSK Occupational Hazard
Category
REPRODUCTIVE HAZARD
GSK Occupational 600 mcg/m3 (8 HR TWA)
Exposure Limit
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None required for normal handling. Wash hands and arms thoroughly after handling.
Other Equipment or
Procedures
9. PHYSICAL AND CHEMICAL PROPERTIES
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Appearance
White.
Colour
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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: an anti-viral agent.
Pharmacological Effects
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No specific target organ effects have been identified.
Target Organ Effects
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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, 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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Contains components which have been classified as: Possible risk of toxicity in developing
Reproductive Effects
human offspring.
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The following adverse effects have been noted with therapeutic use of this material:
Other Adverse Effects
abdominal pain; headache; nausea; vomiting; fatigue; rash.
12. ECOLOGICAL INFORMATION
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This material contains an active pharmaceutical ingredient that has been tested, and no
Summary
environmental effects have been identified. Local regulations and procedures should be
consulted prior to environmental release.
Specific information on the active pharmaceutical ingredient is provided below.
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ECOTOXICITY
Aquatic
This material contains an active pharmaceutical ingredient that is not
Microbial Growth
toxic to these microorganisms.
Inhibition
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> 1000 mg/l, , Azotobacter beijerinckii
Minimum Inhibition
> 1000 mg/l, , Pseudomonas aeruginosa
Concentration:
> 1000 mg/l, , Trichoderma harzianum
> 1000 mg/l, , Aspergillus niger
> 1000 mg/l, , Nostoc commune
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This material contains an active pharmaceutical ingredient that is not
Algal
toxic to algae.
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SDS Number 110551 Approved/Revised 03-Jul-2008 Version 11
EPIVIR TABLETS 150 MG
Material
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IC50: > 96.9 mg/l, 72 Hours, Selenastrum
capricornutum, green algae
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NOEC: > 96.9 mg/l, 72 Hours, Selenastrum
capricornutum, green algae
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This material contains an active pharmaceutical ingredient that is not
Daphnid
toxic to daphnids.
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EC50: > 1000 mg/l, 48 Hours, Daphnia magna, Static
test
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NOEC: > 1000 mg/l, 48 Hours, Daphnia magna, Static
test
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Chronic EC50: > 100 mg/l, 7 Days, Ceriodaphnia dubia, 7 day
static renewal
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Chronic LOEC: > 100 mg/l, 7 Days, Ceriodaphnia dubia
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Chronic NOEC: 100 mg/l, 7 Days, Ceriodaphnia dubia
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This material contains an active pharmaceutical ingredient that is not
Fish
toxic to fish.
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Juvenile Oncorhyncus mykiss, rainbow trout
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EC50: > 97.7 mg/l, 96 Hours, Static test
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MOBILITY
This material contains an active pharmaceutical ingredient that for environmental fate
Solubility
predictions has solubility in water.
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This material contains an active pharmaceutical ingredient that will not readily enter into air
Volatility
from water.
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Henrys Law Constant 1.00E-13 atm m3/mol, Estimated
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This material contains an active pharmaceutical ingredient that is not likely to adsorb to soil
Adsorption
or sediment if released directly to the environment.
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Soil Sediment Sorption 1.5 to 2.03, Measured
(log Koc):
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This material 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 material contains an active pharmaceutical ingredient that is unlikely to undergo
Photolysis
photodegradation.
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UV/Visible Spectrum: 271 nm at pH 7
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This material contains an active pharmaceutical ingredient that is not readily biodegradable
Biodegradation
(as defined by 1993 OECD Testing Guidelines).
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Aerobic - Ready
Percent Degradation: < 1 %, 28 days, Modified Sturm test.
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Aerobic - Inherent
Percent Degradation: 4 %, 28 days, Modified Zahn-Wellens, primary biodegradation,
loss of parent., Activated sludge
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Aerobic - Inherent
Percent Degradation: 0 %, 28 days, Modified Zahn-Wellens, DOC removal., Activated
sludge
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Aerobic - Soil
Percent Degradation: 15 to 24 %, 64 days
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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 110551 Approved/Revised 03-Jul-2008 Version 11
EPIVIR TABLETS 150 MG
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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11
SDS Version Number
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SDS Sections Updated
Sections Subsections
COMPOSITION / INFORMATION ON INGREDIENTS
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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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