SDS Number 110541 Approved/Revised 03-Jul-2008 Version 10
COMBIVIR TABLETS
Material
SAFETY DATA SHEET
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
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Material COMBIVIR TABLETS
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COMBIVIR TABLETS 150 MG/300 MG * COMBIVIR COMPRESSE * COMBIVIR
Synonym(s)
COMPRIMES * COMBIVIR COMPRIMIDOS * COMBIVIR COMPRIMIDOS RECUBIERTOS *
COMBIVIR COMPRIMIDOS REVESTIDOS * COMBIVIR FILMOM OBALENE TABLETY *
COMBIVIR FILMTABLETTEN * COMBIVIR POTAHOVANE TABLETY * COMBIVIR
TABLETAS * COMBIVIR TABLETE * COMBIVIR TABLETES * COMBIVIR TABLETKI
POWLEKANE * COMBIVIR TABLETTA * COMBIVIR TABLETTEN * COMBIVIR TABLETTER
* COMBIVIR TABLETTI * 3TC COMPLEX COMPRIMIDOS * COMBID 300 TABLETS * NDC
NO 0173-0595-00 * NDC NO 0173-0595-02 * LAMIVUDINE AND ZIDOVUDINE,
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 17.6
NON-HAZARDOUS INGREDIENTS Unassigned 47.2
ZIDOVUDINE 30516-87-1 35.2
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.
May produce mutagenic effects in human cells.
Limited evidence of carcinogenic effect.
Exposure might occur via skin; eyes; ingestion.
Health effects information is based on hazards of components.
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SDS Number 110541 Approved/Revised 03-Jul-2008 Version 10
COMBIVIR TABLETS
Material
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No environmental hazards have been identified for this material.
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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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
Treat according to locally accepted protocols. For additional guidance, refer to the current
Medical Treatment
prescribing information or to the local poison control information centre.
Medical treatment in cases of overexposure should be treated as an overdose of an anti-viral
agent.
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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.
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SDS Number 110541 Approved/Revised 03-Jul-2008 Version 10
COMBIVIR TABLETS
Material
8. EXPOSURE CONTROLS / PERSONAL PROTECTION
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ZIDOVUDINE
INGREDIENT
2
GSK Occupational Hazard
Category
CARCINOGEN
GSK Occupational 350 mcg/m3 (8 HR TWA)
Exposure Limit
LAMIVUDINE
INGREDIENT
2
GSK Occupational Hazard
Category
REPRODUCTIVE HAZARD
GSK Occupational 600 mcg/m3 (8 HR TWA)
Exposure Limit
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Follow all local regulations if personal protective equipment (PPE) is used in the workplace.
Other Equipment or
Wear appropriate clothing to avoid skin contact. Wash hands and arms thoroughly after
Procedures
handling.
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: a nucleoside analogue; an
Pharmacological Effects
anti-viral agent.
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Adverse effects might occur in the following organ(s) following overexposure: bone marrow
Target Organ Effects
and formation of blood cells.
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Routes of Exposure
Not expected to be toxic following ingestion. Assessment based upon effects of individual
Oral Toxicity
components.
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Irritation is not expected following direct contact. Assessment based upon effects of
Skin Effects
individual components.
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Irritation is not expected following direct contact with eyes. Assessment based upon effects of
Eye Effects
individual components.
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Sensitisation (allergic skin reaction) is not expected. Assessment based upon effects of
Sensitisation
individual components.
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Possible human mutagen. Assessment based upon effects of individual components.
Genetic Toxicity
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Possible human carcinogen. Assessment based upon effects of individual components.
Carcinogenicity
Not expected to produce cancer in humans under occupational exposure conditions.
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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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None known for occupational exposure.
Other Adverse Effects
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SDS Number 110541 Approved/Revised 03-Jul-2008 Version 10
COMBIVIR TABLETS
Material
12. ECOLOGICAL INFORMATION
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No information is available about the potential of this product to produce adverse
Summary
environmental effects. This material contains two or more active pharmaceutical ingredients
that have been tested, and no environmental effects have been identified. Consult the MSDS
of each ingredient for specific information about potential environmental effects. Local
regulations and procedures should be consulted prior to environmental release.
Specific information on the active pharmaceutical ingredient which is the majority component
is provided below.
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ECOTOXICITY
Aquatic
This material is not toxic to activated sludge microorganisms. This
Activated Sludge
material contains an active pharmaceutical ingredient that is not toxic
Respiration
to activated sludge microorganisms.
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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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250 mg/l, , Aspergillus flavus
Minimum Inhibition
> 1000 mg/l, , Azotobacter chroococcum
Concentration:
> 1000 mg/l, , Chaetomium globosum
> 1000 mg/l, , Nostoc sp.
> 1000 mg/l, , Pseudomonas fluorescens
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This material contains an active pharmaceutical ingredient that is not
Daphnid
toxic to daphnids.
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EC50: > 100 mg/l, 48 Hours, Daphnia magna, Static
test
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Chronic LOEC: 40 mg/l, 21 Days, Daphnia magna, Static
renewal test
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Chronic NOEC: 16 mg/l, 21 Days, Daphnia magna, Static
renewal 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 the
Volatility
air from hard surfaces or from a container of the pure substance.
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Henrys Law Constant 3.50E-15 atm m3/mol, Estimated at 25 C
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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. This material 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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Soil Sediment Sorption 1.1, Estimated at pH 7
(log Koc):
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Sludge Biomass 1.34 Measured at pH 7
Distribution Coefficient
(log Kd):
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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 has been shown to be
Photolysis
chemically unstable in water when exposed to light. Aqueous photolysis may be a significant
depletion mechanism.
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Half-Life, Aqueous: 9.04 Hours, Measured, pH 7 Buffer Solution
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SDS Number 110541 Approved/Revised 03-Jul-2008 Version 10
COMBIVIR TABLETS
Material
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UV/Visible Spectrum: 266 nm
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This material contains an active pharmaceutical ingredient that is not readily biodegradable
Biodegradation
but is inherently biodegradable (as defined by 1993 OECD Testing Guidelines) and is not
expected to persist in the environment.
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Aerobic - Ready
Percent Degradation: 0.23 %, 28 days, Modified Sturm test., Activated sludge
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Aerobic - Ready
Percent Degradation: 50 %, 3 days, , Activated sludge
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Aerobic - Inherent
Percent Degradation: 50 %, 3 days, Modified Zahn-Wellens, primary biodegradation,
loss of parent., 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.
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. Wherever
possible, disposal should be in an on-site licenced chemical incinerator, if allowed by the
incinerator licence or permit. If no on-site incinerator is available, dispose of material in a
licenced commercial chemical incinerator.
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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
HANDLING AND STORAGE General Requirements
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SDS Number 110541 Approved/Revised 03-Jul-2008 Version 10
COMBIVIR TABLETS
Material
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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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