SDS Number 110618 Approved/Revised 07-Jul-2008 Version 18
AVANDAMET
Material
SAFETY DATA SHEET
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
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Material AVANDAMET
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AVANDIA/METFORMIN COMBINATION TABLET * ROSIGLITAZONE 1 MG + METFORMIN
Synonym(s)
500 MG TABLET * ROSIGLITAZONE 2 MG + METFORMIN 500 MG TABLET *
ROSIGLITAZONE 4 MG + METFORMIN 500 MG TABLET * ROSIGLITAZONE 2 MG +
METFORMIN 1000 MG TABLET * ROSIGLITAZONE 4 MG + METFORMIN 1000 MG
TABLET * NDC NO. 0007-3167-18 * NDC NO. 0007-3168-18 * NDC NO. 0007-3163-18 *
NDC NO. 0007-3164-18 * ROSIGLITAZONE AND METFORMIN, 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.
METFORMIN HYDROCHLORIDE 1115-70-4 87.7 to 90.9
NON-HAZARDOUS INGREDIENTS Unassigned 8.4 to 11.5
ROSIGLITAZONE MALEATE 155141-29-0 0.5 to 0.9
3. HAZARDS IDENTIFICATION
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Expected to be non-combustible.
Fire and Explosion
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Handling this product in its final form presents minimal risk from occupational exposure.
Health
Health effects information is based on hazards of components.
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This material contains an active pharmaceutical ingredient that may have reproductive or
Environment
developmental effects on environmental organisms.
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SDS Number 110618 Approved/Revised 07-Jul-2008 Version 18
AVANDAMET
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 drug for
Medical Treatment
the treatment of Type 2 diabetes. 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 or foam extinguishers are recommended.
Extinguishing Media
Carbon dioxide or dry powder extinguishers 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 110618 Approved/Revised 07-Jul-2008 Version 18
AVANDAMET
Material
8. EXPOSURE CONTROLS / PERSONAL PROTECTION
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ROSIGLITAZONE MALEATE
INGREDIENT
3
GSK Occupational Hazard
Category
REPRODUCTIVE HAZARD
GSK Occupational 30 mcg/m3 (8 HR TWA)
Exposure Limit
METFORMIN HYDROCHLORIDE
INGREDIENT
1
GSK Occupational Hazard
Category
GSK Occupational 3000 mcg/m3 (8 HR TWA)
Exposure Limit
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ENGINEERING CONTROLS
Open handling may result in overexposure.
Containment
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Local exhaust ventilation (LEV) should be used in conjunction with other control measures as
Ventilation
a means of removing material incidentally released.
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Entry to the working area should be controlled.
Administrative
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Follow all local regulations if personal protective equipment (PPE) is used in the workplace.
Other Equipment or
Wash hands and arms thoroughly after 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 product contains active ingredient(s) with the following activity: a peroxisome proliferator
Pharmacological Effects
activated receptor (PPAR) agonist.
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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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Minor irritation might occur following direct contact.
Skin Effects
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Minor 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: Possible risk of impaired fertility in
Reproductive Effects
human females. Possible risk of toxicity in developing human offspring.
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None known for occupational exposure.
Other Adverse Effects
12. ECOLOGICAL INFORMATION
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This material contains two or more active pharmaceutical ingredients that have been tested,
Summary
one of which may be harmful if released directly to the environment. Specific information on
that active pharmaceutical ingredient, Rosiglitazone maleate, is provided below. Consult the
MSDS of the active ingredient for specific information about potential environmental effects.
Appropriate precautions should be taken to limit release of this material to the environment.
Local regulations and procedures should be consulted prior to environmental release.
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SDS Number 110618 Approved/Revised 07-Jul-2008 Version 18
AVANDAMET
Material
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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,
Nominal
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This material contains an active pharmaceutical ingredient that is very
Algal
toxic to algae.
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IC50: 0.88 mg/L, 96 Hours, Selenastrum
capricornutum, green algae
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NOEC: 0.14 mg/L, 96 Hours, Selenastrum
capricornutum, green algae
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This material contains an active pharmaceutical ingredient that is toxic
Daphnid
to daphnids.
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EC50: 6.8 mg/L, 48 Hours, Daphnia magna, Static test
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Chronic LOEC: 0.32 mg/l, 7 Days, Ceriodaphnia dubia, 7 day
static renewal
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Chronic NOEC: 0.1 mg/L, 7 Days, Ceriodaphnia dubia, 7 day
static renewal
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No toxicity to fish was observed for the active pharmaceutical
Fish
ingredient, but the upper range of the test was limited by the low water
solubility of the compound.
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Juvenile Pimephales promelas, fathead minnow
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EC50: > 14.5 mg/L, 96 Hours, Static renewal test
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MOBILITY
This material contains an active pharmaceutical ingredient that for environmental fate
Solubility
predictions has limited 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 1.69E-14 atm m3/mol, Calculated
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This material contains an active pharmaceutical ingredient that is not likely to adsorb to
Adsorption
sludge or biomass if released directly to the environment.
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Soil Sediment Sorption 1.93, Calculated at pH 7
(log Koc):
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Sludge Biomass 2.8 Measured
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 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 - Inherent
Percent Degradation: 50 %, 1 Day, Batch activated sludge (BAS), 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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Bioconcentration Factor: 7.6 Calculated
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 material.
Regulatory Requirements
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SDS Number 110618 Approved/Revised 07-Jul-2008 Version 18
AVANDAMET
Material
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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18
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. For further
information please refer to the appropriate product information.
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