SDS Number 110541 Approved/Revised 18-Nov-2004 Version 06
Material COMBIVIR TABLET
SAFETY DATA SHEET
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
Material COMBIVIR TABLET
COMBIVIR TABLET 150/300MG * COMBIVIR COMPRESSE * COMBIVIR
Synonyms
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 * NDC NO 0173-0595-00 * NDC NO 0173-0595-02 *
LAMIVUDINE/ZIDOVUDINE, FORMULATED PRODUCT
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
LAMIVUDINE 17.6
134678-17-4
ZIDOVUDINE 35.2
30516-87-1
NON-HAZARDOUS INGREDIENTS 47.2
Unassigned
3. HAZARDS IDENTIFICATION
Expected to be non-combustible.
Fire and Explosion
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SDS Number 110541 Approved/Revised 18-Nov-2004 Version 06
Material COMBIVIR TABLET
Health Caution - Pharmaceutical agent.
Eye irritant.
May produce mutagenic effects in human cells.
Exposure might occur via eyes; skin; ingestion.
Health effects information is based on hazards of components.
* Environment No environmental hazards have been identified for this material.
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 Medical treatment in cases of overexposure should be treated as an
overdose of an anti-viral agent. Treat according to locally accepted
protocols. For additional guidance, refer to the current prescribing
information or to the local poison control information centre.
Medical Conditions None for occupational exposure.
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, dry powder or foam extinguishers are recommended. Carbon
dioxide extinguishers may be ineffective.
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 For large spills, take precautions to prevent entry into waterways, sewers, or
surface drainage systems.
Clean-up Methods Collect and place it in a suitable, properly labelled container for recovery or
disposal.
Decontamination No specific decontamination or detoxification procedures have been
identified for this product.
Procedures
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SDS Number 110541 Approved/Revised 18-Nov-2004 Version 06
Material COMBIVIR TABLET
7. HANDLING AND STORAGE
HANDLING
General Requirements Avoid breaking or crushing capsules.
STORAGE No storage requirements necessary for occupational hazards. Follow
product information storage instructions to maintain efficacy.
8. EXPOSURE CONTROLS/PERSONAL PROTECTION
LAMIVUDINE
INGREDIENT
2
GSK Occupational
Hazard Category
REPRODUCTIVE HAZARD
GSK Occupational 600 mcg/m3 (8 HR TWA)
Exposure Limit
ZIDOVUDINE
INGREDIENT
2
GSK Occupational
Hazard Category
CARCINOGEN
GSK Occupational 350 mcg/m3 (8 HR TWA)
Exposure Limit
ENGINEERING CONTROLS
Exposure Controls An Exposure Control Approach (ECA) is established for operations
involving this material based upon the OEL/Occupational Hazard Category
and the outcome of a site- or operation-specific risk assessment. Refer to
the Exposure Control Matrix for more information about how ECA's are
assigned and how to interpret them.
Containment Open handling may result in overexposure.
Ventilation Local exhaust ventilation (LEV) should be used in conjunction with other
control measures as a means of removing material incidentally released.
PERSONAL PROTECTIVE EQUIPMENT
Eye Protection Wear approved safety glasses with side shields or cover goggles if eye
contact is possible.
Other Equipment or None required for normal handling. Wash hands and arms thoroughly after
handling.
Procedures
9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance
White.
Colour
Tablet.
Physical Form
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 might occur following direct contact with eyes.
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SDS Number 110541 Approved/Revised 18-Nov-2004 Version 06
Material COMBIVIR TABLET
Target Organ Effects Adverse effects might occur in the following organ(s) following
overexposure: bone marrow and formation of blood cells.
Sensitisation Sensitisation (allergic skin reaction) is not expected.
Genetic Toxicity Possible human mutagen.
Carcinogenicity No components are listed as carcinogens by GSK, IARC, NTP or US
OSHA. Positive results occurred in some studies that are not considered to
be relevant to occupational exposure conditions. Not expected to produce
cancer in humans under occupational exposure conditions based upon
negative results in laboratory assays.
Reproductive Effects Contains components which have been classified as: Possible risk of
toxicity in developing human offspring. Not expected to produce adverse
effects on fertility or development under occupational exposure conditions.
Pharmacological Effects This preparation contains ingredient(s) with the following activity: a
nucleoside inhibitor of viral reverse transcriptase
* Other Adverse Effects None known for occupational exposure.
12. ECOLOGICAL INFORMATION
* Summary No information is available about the potential of this product to produce
adverse 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.
ECOTOXICITY
Aquatic
* Activated Sludge This material is not toxic to activated sludge microorganisms. This material
contains an active pharmaceutical ingredient that is not toxic to activated
Respiration
sludge microorganisms.
IC50: > 1000 mg/l, 3 Hours, Activated sludge
* Microbial Growth This material contains an active pharmaceutical ingredient that is not toxic
to these microorganisms.
Inhibition
Minimum Inhibition 250 mg/l, , Aspergillus flavus
Concentration: > 1000 mg/l, , Azotobacter chroococcum
> 1000 mg/l, , Chaetomium globosum
> 1000 mg/l, , Nostoc sp.
> 1000 mg/l, , Pseudomonas fluorescens
* Daphnid This material contains an active pharmaceutical ingredient that is not toxic
to daphids.
EC50: > 100 mg/l, 48 Hours, Daphnia magna, Static test
Chronic LOEC: 40 mg/l, 21 Days, Daphnia magna, Static renewal
test
Chronic NOEC: 16 mg/l, 21 Days, Daphnia magna, Static renewal
test
MOBILITY
* Solubility This material contains an active pharmaceutical ingredient that for
environmental fate predictions has solubility in water.
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SDS Number 110541 Approved/Revised 18-Nov-2004 Version 06
Material COMBIVIR TABLET
* Volatility This material contains an active pharmaceutical ingredient that will not
readily enter into the air from hard surfaces or from a container of the pure
substance.
Henry's Law Constant 3.50E-15 atm m^3/mol, Estimated at 25 C
* Adsorption This material contains an active pharmaceutical ingredient that is not likely
to adsorb to soil 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.
Soil Sediment Sorption 1.1, Estimated at pH 7
(log Koc):
Sludge Biomass 1.34 Measured Measured at pH 7
Distribution Coefficient
(log Kd):
* Partitioning This material contains an active pharmaceutical ingredient with
octanol/water partition coefficient data that suggests that for environmental
fate predictions the active pharmaceutical ingredient will not have the
tendency to distribute into fats.
PERSISTENCE/DEGRADATION
* Hydrolysis This material contains an active pharmaceutical ingredient that has been
shown to be chemically stable in water. Hydrolysis is unlikely to be a
significant depletion mechanism.
Half-Life, Neutral: > 1 Years, Measured
* Photolysis This material contains an active pharmaceutical ingredient that has been
shown to be chemically unstable in water when exposed to light. Aqueous
photolysis may be a significant depletion mechanism.
Half-Life, Aqueous: 9.04 Hours, Measured, pH 7 Buffer Solution
UV/Visible Spectrum: 266 nm
* Biodegradation This material contains an active pharmaceutical ingredient that is not
readily biodegradable but is inherently biodegradable (as defined by 1993
OECD Testing Guidelines) and is not expected to persist in the
environment.
Aerobic - Ready
Percent Degradation: 0.23 %, 28 days, Modified Sturm test., Activated
sludge
Percent Degradation: 50 %, 3 days, , Activated sludge
Aerobic - Inherent
Percent Degradation: 50 %, 3 days, Modified Zahn-Wellens, primary
biodegradation, loss of parent., Activated sludge
* BIOACCUMULATION This material contains an active pharmaceutical ingredient that will not have
a tendency to bioaccumulate in the food chain.
13. DISPOSAL CONSIDERATIONS
Disposal Collect for recycling or recovery if possible. The disposal method for
rejected products/returned goods must ensure that they cannot be re-sold or
Recommendations
re-used.
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 110541 Approved/Revised 18-Nov-2004 Version 06
Material COMBIVIR TABLET
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
Exempt from requirements of EU Dangerous Preparations directive - product regulated as a medicinal
product, cosmetic product or medical device.
US OSHA Standard (29 CFR Part 1910.1200)
Classification This dosage form 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 18-Nov-2004 SDS Version Number 6
SDS Sections Updated
Sections Subsections
COMPOSITION / INFORMATION ON INGREDIENTS
ECOLOGICAL INFORMATION Activated Sludge Respiration
Adsorption
Algal
Algal Degradation
Bioaccumulation
Biodegradation
Daphnid
Distribution
Earthworm
Ecotoxicity
Fish
Hydrolysis
Microbial Growth Inhibition
Microtox
Mobility
Other Adverse Effects
Other Species - Aquatic
Other Species - Terrestrial
Partitioning
Persistence/Degradation
Photolysis
Solubility
Summary
Volatility
HAZARDS IDENTIFICATION Environment
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SDS Number 110541 Approved/Revised 18-Nov-2004 Version 06
Material COMBIVIR TABLET
SDS Sections Updated
Sections Subsections
REGULATORY INFORMATION European Union Classification and Labelling
Requirements
TOXICOLOGY INFORMATION Other Adverse Effects
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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